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    BIOMARKER:

    EGFR wild-type + ALK wild-type

    i
    Other names: EGFR, ERBB, ERBB1, Epidermal growth factor receptor, NBLST3, CD246, Anaplastic Lymphoma Kinase, Anaplastic Lymphoma Kinase (Ki-1), CD246 Antigen, Mutant Anaplastic Lymphoma Kinase, ALK, ALK Receptor Tyrosine Kinase, Anaplastic Lymphoma Receptor Tyrosine Kinase, ALK Tyrosine Kinase Receptor
    Entrez ID:
    1956; 238
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    1m
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    2ms
    Proteogenomic characterization identifies clinical subgroups in EGFR and ALK wild-type never-smoker lung adenocarcinoma. (PubMed, Exp Mol Med)
    Upregulated cytokines, such as CCL5 and CXCL13, in the immune subgroup may serve as potential targets for combination immunotherapy. Our comprehensive proteogenomic analysis revealed the molecular subtypes of EGFR- and ALK-wild-type NSLA with significant unmet clinical needs.
    Journal • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CXCL13 (Chemokine (C-X-C motif) ligand 13)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    2ms
    SILK BM: A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation (clinicaltrials.gov)
    P2, N=4, Completed, Institut Claudius Regaud | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Aug 2024 | Trial primary completion date: Dec 2025 --> Aug 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    8ms
    AK105-301: A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=164, Terminated, Akeso | Trial completion date: Jun 2024 --> Dec 2023 | Active, not recruiting --> Terminated; corporate strategy adjustment
    Trial completion date • Trial termination • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    carboplatin • Focus V (anlotinib) • pemetrexed • Anniko (penpulimab)
    9ms
    Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) (clinicaltrials.gov)
    P2, N=140, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2027 --> Apr 2026
    Enrollment open • Trial primary completion date • Surgery
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    9ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=121, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    9ms
    PACIFIC-8: A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (clinicaltrials.gov)
    P3, N=860, Recruiting, AstraZeneca | Trial completion date: Sep 2029 --> Aug 2030 | Trial primary completion date: Jun 2027 --> Jun 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    9ms
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    10ms
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=122, Terminated, Novartis Pharmaceuticals | Active, not recruiting --> Terminated; Business reasons
    Trial termination • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    11ms
    A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=121, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=90 --> 121
    Enrollment change • Combination therapy • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    11ms
    A Study of BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    1year
    Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, AstraZeneca | Trial completion date: Apr 2027 --> Sep 2027 | Trial primary completion date: Apr 2026 --> Mar 2027
    Trial completion date • Trial primary completion date • Surgery
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    1year
    A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=584, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • KRAS G12V • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR wild-type + ALK wild-type • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    over1year
    ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov)
    P1, N=279, Active, not recruiting, Jazz Pharmaceuticals | Trial completion date: Aug 2023 --> Jul 2024 | Trial primary completion date: Jun 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • HER-2 overexpression • EGFR wild-type • KRAS wild-type • ALK wild-type • RAS wild-type • EGFR wild-type + ALK wild-type • ALK-ROS1 fusion
    |
    paclitaxel • capecitabine • Tukysa (tucatinib) • vinorelbine tartrate • zanidatamab (ZW25)
    over1year
    A Study of BL-B01D1+SI-B003 in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=90, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Metastases
    |
    EGFR wild-type • EGFR wild-type + ALK wild-type
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    over1year
    A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=584, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • BRAF V600 • KRAS G12D • EGFR wild-type • KRAS G12V • RET mutation • ALK wild-type • ROS1 fusion • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • KRAS amplification • EGFR wild-type + ALK wild-type • NTRK fusion
    |
    docetaxel • izalontamab (SI-B001)
    over1year
    Treatment patterns and outcomes of patients with metastatic non-small cell lung cancer in five European countries: a real-world evidence survey. (PubMed, BMC Cancer)
    Real-world treatment patterns suggest that chemotherapy use remains high despite guidelines recommending immunotherapy-based 1L treatment for mNSCLC. QoL reported by patients was generally lower than population reference values. Not implying causality, 1L immunotherapy use was higher during COVID-19 than pre-COVID-19, and the UK saw the biggest impact to patient management due to COVID-19.
    Journal • HEOR • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • EGFR wild-type • ALK mutation • ALK wild-type • EGFR wild-type + ALK wild-type • EGFR mutation + ALK mutation
    over1year
    Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE) (clinicaltrials.gov)
    P2, N=140, Not yet recruiting, AstraZeneca
    New P2 trial • Surgery
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    over1year
    PEOPLE (NTC03447678), a phase II trial to test pembrolizumab as first-line treatment in patients with advanced NSCLC with PD-L1 <50%: a multiomics analysis. (PubMed, J Immunother Cancer)
    P=N/A; This multiomics approach was able to identify immune cell subsets and expression levels of genes associated to PFS in patients with PD-L1 <50% NSCLC treated with first-line pembrolizumab. These preliminary data will be confirmed in the larger multicentric international I3LUNG trial (NCT05537922).
    Journal • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • KLRB1 (Killer Cell Lectin Like Receptor B1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    nCounter® PanCancer IO 360™ Panel
    |
    Keytruda (pembrolizumab)
    over1year
    Cost-effectiveness evaluation based on two models of first-line atezolizumab monotherapy and chemotherapy for advanced non-small cell lung cancer with high-PDL1 expression. (PubMed, Front Oncol)
    In some areas of China with higher levels of economic development, atezolizumab was likely to be cost-effective. To improve the cost-effectiveness of atezolizumab, drug prices would need to be reduced.
    Journal • HEOR • PD(L)-1 Biomarker • IO biomarker • Cost-effectiveness • Cost effectiveness • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression • EGFR expression • EGFR wild-type • EGFR overexpression • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Tecentriq (atezolizumab)
    over1year
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=122, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting | N=185 --> 122 | Trial completion date: Apr 2025 --> Oct 2023 | Trial primary completion date: Apr 2025 --> Oct 2023
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    almost2years
    SILK BM: A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation (clinicaltrials.gov)
    P2, N=4, Active, not recruiting, Institut Claudius Regaud | Recruiting --> Active, not recruiting | N=50 --> 4
    Enrollment closed • Enrollment change • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab)
    almost2years
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=185, Recruiting, Novartis Pharmaceuticals | Trial completion date: Sep 2024 --> Apr 2025 | Trial primary completion date: Sep 2024 --> Apr 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    2years
    ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov)
    P1, N=279, Active, not recruiting, Zymeworks Inc. | Trial completion date: Oct 2022 --> Aug 2023 | Trial primary completion date: Sep 2022 --> Jun 2023
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • HER-2 overexpression • EGFR wild-type • KRAS wild-type • ALK wild-type • RAS wild-type • EGFR wild-type + ALK wild-type • ALK-ROS1 fusion
    |
    paclitaxel • capecitabine • Tukysa (tucatinib) • vinorelbine tartrate • zanidatamab (ZW25)
    2years
    AK105-301: A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=164, Active, not recruiting, Akeso | Unknown status --> Active, not recruiting | N=360 --> 164 | Trial completion date: Nov 2021 --> Jun 2024 | Trial primary completion date: Nov 2020 --> Jun 2023
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    carboplatin • Focus V (anlotinib) • pemetrexed • Anniko (penpulimab)
    2years
    Study of ceralasertib plus durvalumab versus docetaxel for patients with advanced or metastatic non-small cell lung cancer A ceralasertib és a hozzáadott durvalumab vizsgálata a docetaxellel szemben előrehaladott vagy metasztatikus nem kissejtes tüdőrákban szenvedő betegeknél (clinicaltrialsregister.eu)
    P3, N=580, Ongoing, AstraZeneca AB
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • docetaxel • ceralasertib (AZD6738)
    over2years
    Association Between EGFR and ALK Mutation Status on Patient-Reported Symptoms After Palliative Radiation for Bone Pain in NSCLC. (PubMed, JTO Clin Res Rep)
    ALK+ mutation status was associated with a higher rate of complete response compared with WT (OR = 5.2, p = 0.031). There was an association between EGFR+ and ALK+ tumors and increased rates of partial pain response to palliative radiotherapy.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK rearrangement • EGFR wild-type • ALK mutation • ALK wild-type • EGFR wild-type + ALK wild-type • EGFR mutation + ALK mutation
    over2years
    A Global Study to Assess the Effects of Durvalumab with Oleclumab or Durvalumab with Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9) Ensayo mundial para evaluar los efectos de Durvalumab con Oleclumab o Durvalumab con Monalizumab tras la quimiorradioterapia simultánea en pacientes con cáncer de pulmón no microcítico irresecable en estadio III (PACIFIC-9) (clinicaltrialsregister.eu)
    P3, N=1670, Ongoing, AstraZeneca AB
    New P3 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR mutation • EGFR wild-type • ALK mutation • ALK wild-type • EGFR wild-type + ALK wild-type • PD-L1 deletion
    |
    Imfinzi (durvalumab) • oleclumab (MEDI9447) • monalizumab (IPH2201)
    over2years
    PEOPLE (NTC03447678), a phase II trial of first-line, single-agent pembrolizumab in advanced NSCLC with low PD-L1: Clinical outcomes and association with circulating immune biomarkers. (ASCO 2022)
    This trial confirmed that pembrolizumab as first-line single agent is safe and active also in a subgroup of aNSCLC patients with PD-L1 < 50%. CIP biomarkers can be useful to identify patients with a favourable outcome, thus avoiding the adding toxicity of chemotherapy.
    Clinical • Clinical data • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • CD19 (CD19 Molecule) • NCAM1 (Neural cell adhesion molecule 1)
    |
    EGFR wild-type • ALK wild-type • CD19 expression • EGFR wild-type + ALK wild-type
    |
    Keytruda (pembrolizumab)
    over2years
    PEOPLE (NTC03447678), a phase II trial to test pembrolizumab as first-line treatment in patients with advanced NSCLC with PD-L1 < 50%: A multiomics approach. (ASCO 2022)
    To the best of our knowledge, this is the first prospective trial in NSCLC with PD-L1 < 50% performed with a multi-omic approach able to identify immune cell subsets and expression levels of genes associated to PFS under first line treatment with pembrolizumab.
    P2 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • KLRB1 (Killer Cell Lectin Like Receptor B1)
    |
    PD-L1 expression • EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    nCounter® PanCancer IO 360™ Panel
    |
    Keytruda (pembrolizumab)
    over2years
    A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC 8) (clinicaltrials.gov)
    P3; N=1570; Ongoing; Sponsor:AstraZeneca AB
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    over2years
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Phase classification: P2/3 --> P2
    Phase classification • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)
    over2years
    PACIFIC-8: A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (clinicaltrials.gov)
    P3, N=860, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting | Trial primary completion date: Mar 2026 --> Jun 2027
    Enrollment open • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    over2years
    PACIFIC-9: A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=999, Recruiting, AstraZeneca | Trial completion date: Oct 2030 --> May 2030
    Trial completion date • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • oleclumab (MEDI9447) • monalizumab (IPH2201)
    over2years
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=185, Recruiting, Novartis Pharmaceuticals | N=126 --> 185
    Enrollment change • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    over2years
    ZWI-ZW25-101: Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers (clinicaltrials.gov)
    P1, N=279, Active, not recruiting, Zymeworks Inc. | Recruiting --> Active, not recruiting | N=418 --> 279 | Trial completion date: Mar 2022 --> Oct 2022 | Trial primary completion date: Jan 2022 --> Sep 2022
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 positive • HER-2 overexpression • EGFR wild-type • KRAS wild-type • ALK wild-type • RAS wild-type • EGFR wild-type + ALK wild-type • ALK-ROS1 fusion
    |
    paclitaxel • capecitabine • Tukysa (tucatinib) • vinorelbine tartrate • zanidatamab (ZW25)
    over2years
    PACIFIC-9: A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=999, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • oleclumab (MEDI9447) • monalizumab (IPH2201)
    over2years
    Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies (clinicaltrials.gov)
    P1, N=126, Recruiting, Novartis Pharmaceuticals | Trial completion date: Oct 2023 --> Sep 2024 | Trial primary completion date: Oct 2023 --> Sep 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase)
    |
    KRAS G12C • EGFR wild-type • KRAS wild-type • RAS wild-type • KRAS G12 • EGFR wild-type + ALK wild-type
    |
    Kisqali (ribociclib) • spartalizumab (PDR001) • batoprotafib (TNO155)
    almost3years
    PACIFIC-9: A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=1000, Not yet recruiting, AstraZeneca
    New P3 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • oleclumab (MEDI9447) • monalizumab (IPH2201)
    almost3years
    PACIFIC-8: A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (clinicaltrials.gov)
    P3, N=860, Not yet recruiting, AstraZeneca
    New P3 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    almost3years
    SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC. (clinicaltrials.gov)
    P2/3, N=60, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    cisplatin • paclitaxel • docetaxel • pemetrexed • izalontamab (SI-B001)