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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
    22d
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    4ms
    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)
    4ms
    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)
    6ms
    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)
    8ms
    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)
    9ms
    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)
    9ms
    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)
    10ms
    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)
    10ms
    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
    10ms
    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)
    11ms
    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)
    1year
    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)
    1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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)
    over1year
    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
    almost2years
    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)
    almost2years
    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)
    almost2years
    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)
    2years
    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)
    2years
    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)
    2years
    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)
    2years
    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)
    2years
    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)
    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. | 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)
    2years
    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)
    2years
    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)
    2years
    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)
    2years
    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)
    over2years
    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)