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    CANCER:

    Lung Non-Small Cell Squamous Cancer

    Related cancers:
    2d
    A Study to Assess Efficacy and Safety of Pembrolizumab With or Without MK- 2870 in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (clinicaltrials.gov)
    P3, N=780, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open • Surgery
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
    2d
    IBFIC: Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, Samsung Medical Center | Trial primary completion date: Dec 2023 --> Dec 2025
    Trial primary completion date • Checkpoint inhibition • IO biomarker
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab)
    2d
    Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC (clinicaltrials.gov)
    P3, N=48, Recruiting, Maximilian Diehn | Trial completion date: Mar 2026 --> Apr 2028 | Trial primary completion date: Mar 2024 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • Imjudo (tremelimumab) • pemetrexed
    3d
    Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, National Cancer Institute (NCI) | N=106 --> 12 | Trial completion date: Aug 2024 --> Apr 2025 | Trial primary completion date: Aug 2024 --> Mar 2024
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • berzosertib (M6620)
    4d
    DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, University of Alabama at Birmingham
    New P2 trial • Checkpoint inhibition
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Yervoy (ipilimumab) • carboplatin • paclitaxel • pemetrexed
    7d
    A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients (clinicaltrials.gov)
    P2, N=120, Recruiting, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
    New P2 trial • Metastases
    10d
    BFAST: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=1000, Recruiting, Hoffmann-La Roche | Trial completion date: Apr 2024 --> Aug 2028 | Trial primary completion date: Apr 2024 --> Aug 2028
    Trial completion date • Trial primary completion date • Tumor mutational burden • Metastases
    |
    BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden)
    |
    Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • carboplatin • gemcitabine • Rozlytrek (entrectinib) • docetaxel • Alecensa (alectinib) • Cotellic (cobimetinib) • pemetrexed • divarasib (RG6330)
    11d
    STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=720, Recruiting, Gilead Sciences | Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2027 --> Sep 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • ALK mutation • RET mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    11d
    A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=180, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • tobemstomig (RG6139)
    14d
    Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy (clinicaltrials.gov)
    P2, N=80, Recruiting, Wake Forest University Health Sciences | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed
    16d
    A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=350, Completed, Akeso | Unknown status --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • paclitaxel • Anniko (penpulimab)
    21d
    Tipifarnib in Advanced Squamous NSCLC With Oncogen HRAS MutAtionS (clinicaltrials.gov)
    P2, N=9, Terminated, Spanish Lung Cancer Group | Active, not recruiting --> Terminated; The recruitment was closed prematurely to due to slow recruitment.
    Trial termination • Metastases
    |
    HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    HRAS mutation
    |
    Zarnestra (tipifarnib)
    23d
    CHRYSALIS: Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=751, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2024 --> Jun 2025
    Trial completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • MET amplification • EGFR exon 20 insertion • EGFR wild-type • MET exon 14 mutation • EGFR C797S • MET mutation • MET expression • EGFR exon 20 mutation • EGFR positive
    |
    carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Leclaza (lazertinib)
    24d
    ORIENT-99: Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer (clinicaltrials.gov)
    P3, N=500, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel • pemetrexed
    29d
    Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=534, Not yet recruiting, Shanghai JMT-Bio Inc.
    New P2/3 trial
    |
    docetaxel • becotarug (JMT101)
    29d
    SQUIRE: First-line Treatment of Participants With Stage IV Squamous Non-Small Cell Lung Cancer With Necitumumab and Gemcitabine-Cisplatin (clinicaltrials.gov)
    P3, N=1093, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2023 --> Jun 2024
    Trial completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • EGFR mutation • EGFR mutation + KRAS mutation
    |
    cisplatin • gemcitabine • Portrazza (necitumumab)
    29d
    Calypso Guided High Precision Stereotactic Ablative Radiosurgery for Lung TUmours Using Real-Time Tumour Tracking & Respiratory Gating (clinicaltrials.gov)
    P=N/A, N=28, Active, not recruiting, CancerCare Manitoba | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> PN/A | Trial primary completion date: Dec 2021 --> Jan 2025
    Enrollment closed • Phase classification • Trial primary completion date • Surgery
    1m
    A Study to Assess Efficacy and Safety of Pembrolizumab With or Without MK- 2870 in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (clinicaltrials.gov)
    P3, N=780, Not yet recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Surgery
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • pemetrexed • sacituzumab tirumotecan (MK-2870)
    1m
    VIGOR: Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (clinicaltrials.gov)
    P4, N=15, Active, not recruiting, Galvanize Therapeutics, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK mutation
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed • vinorelbine tartrate
    1m
    Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, National Cancer Institute (NCI)
    Trial completion date • Surgery • Metastases
    |
    Avastin (bevacizumab) • cisplatin • docetaxel • etoposide IV • Vegzelma (bevacizumab-adcd) • Avzivi (bevacizumab-tnjn) • Neulasta (pegfilgrastim) • Neupogen (filgrastim)
    1m
    KEYNOTE-D13: A Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=320, Active, not recruiting, SOTIO Biotech AG | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2023 --> Apr 2025
    Enrollment closed • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • nanrilkefusp alfa (SOT101)
    1m
    Sintilimab With Pemigatinib in Patients With PD-L1-positive and FGFR Mutated Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Trial completion date: Sep 2023 --> Sep 2025
    Trial completion date • IO biomarker • Metastases
    |
    TNFRSF9 (TNF Receptor Superfamily Member 9)
    |
    PD-L1 expression • FGFR1 mutation
    |
    Tyvyt (sintilimab) • Pemazyre (pemigatinib)
    1m
    Study Comparing Two Different Schedules of Radiation for Early-stage Lung Cancer (clinicaltrials.gov)
    P=N/A, N=100, Recruiting, University of Rochester | Phase classification: P2 --> P=N/A
    Phase classification
    1m
    ITIL-306 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=51, Active, not recruiting, Instil Bio | Phase classification: P1a/1b --> P1
    Phase classification • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    cyclophosphamide • ITIL-306
    1m
    Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.(RadmiR-01) (clinicaltrials.gov)
    P=N/A, N=240, Completed, Xinqiao Hospital of Chongqing | Unknown status --> Completed
    Trial completion • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR wild-type
    2ms
    Sintilimab with two cycles of chemotherapy for the treatment of advanced squamous non-small cell lung cancer: a phase 2 clinical trial. (PubMed, Nat Commun)
    Biomarker analysis revealed that the breast cancer gene 2, BMP/Retinoic Acid Inducible Neural Specific 3, F-box/WD repeat-containing protein 7, tyrosine-protein kinase KIT and retinoblastoma 1 abnormalities led to shorter PFS, while ctDNA negative at baseline or clearance at 2 cycles of treatment was associated with longer PFS (18.1 vs. 4.3 months). Taken together, sintilimab in combination with 2 cycles of nab-paclitaxel/carboplatin treatment produced encouraging PFS and better tolerability as first-line treatment for advanced sq-NSCLC.
    P2 data • Clinical Trial,Phase II • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    RB1 (RB Transcriptional Corepressor 1) • BRINP3 (BMP/Retinoic Acid Inducible Neural Specific 3)
    |
    carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel
    2ms
    EVOKE-01: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P3, N=603, Active, not recruiting, Gilead Sciences | Trial primary completion date: May 2024 --> Nov 2023
    Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    docetaxel • Trodelvy (sacituzumab govitecan-hziy)
    2ms
    VIGOR: Neoadjuvant Aliya™ PEF Soft Tissue Ablation With Systemic Therapy in Early-Stage Resectable NSCLC (clinicaltrials.gov)
    P4, N=15, Recruiting, Galvanize Therapeutics, Inc. | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    EGFR mutation • ALK mutation
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed • vinorelbine tartrate
    2ms
    PEMBRO-K : Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in NSCLC (clinicaltrials.gov)
    P=N/A, N=75, Not yet recruiting, University Hospital, Angers | Trial completion date: Aug 2026 --> Apr 2026
    Trial completion date
    |
    Keytruda (pembrolizumab)
    2ms
    CA209-6K6: An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=52, Recruiting, Montefiore Medical Center | Trial completion date: Aug 2027 --> Jul 2025
    Trial completion date • Tumor mutational burden
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • pemetrexed
    2ms
    KEYMAKER-U01 Substudy 1: Efficacy and Safety Study of Pembrolizumab (MK-3475) Plus Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A) (clinicaltrials.gov)
    P2, N=360, Active, not recruiting, Merck Sharp & Dohme LLC | Trial completion date: Feb 2032 --> Feb 2039 | Trial primary completion date: Feb 2032 --> Feb 2039
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • vibostolimab (MK-7684) • MK-0482 • MK-4830
    2ms
    MGD019 DART® Protein in Unresectable/Metastatic Cancer (clinicaltrials.gov)
    P1, N=162, Active, not recruiting, MacroGenics | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Jul 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • BRAF mutation • EGFR T790M • ALK rearrangement • ROS1 rearrangement
    |
    lorigerlimab (MGD019)
    2ms
    Neoadjuvant and Adjuvant Therapy Studies of Sindilizumab in Resectable Lung Cancer (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd. | N=800 --> 500 | Trial completion date: Jun 2026 --> Oct 2028 | Trial primary completion date: Aug 2023 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • Tyvyt (sintilimab) • albumin-bound paclitaxel • pemetrexed
    2ms
    SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=188, Terminated, Sinocelltech Ltd. | N=360 --> 188 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2022 --> Feb 2023; Strategy adjustments, independent of the safety and efficacy of the trial medication
    Enrollment change • Trial termination • Trial primary completion date • Metastases
    |
    EGFR mutation
    |
    docetaxel • finotonlimab (SCT-I10A)
    2ms
    A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008) (clinicaltrials.gov)
    P3, N=591, Active, not recruiting, Merck Sharp & Dohme LLC | N=857 --> 591 | Trial primary completion date: May 2024 --> Sep 2023
    Enrollment change • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Lynparza (olaparib) • carboplatin • albumin-bound paclitaxel
    2ms
    Epidemiology and Outcomes of Non-Small Cell Lung Cancer in South Korea. (PubMed, JAMA Netw Open)
    This study, which pooled medical data from multiple clinical data warehouses to produce a large study cohort, may provide meaningful insights into the clinical practice of NSCLC and underscores the value of a common data model approach. The analyzable dataset may hold great promise for future comprehensive identification of subpopulations and unmet needs.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • EGFR positive
    2ms
    LCD: Lung Cancer With Copanlisib and Durvalumab (clinicaltrials.gov)
    P1, N=11, Active, not recruiting, Zhonglin Hao | Recruiting --> Active, not recruiting | N=18 --> 11 | Trial completion date: Jun 2031 --> Jun 2025 | Trial primary completion date: Jun 2031 --> Jun 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Imfinzi (durvalumab) • Aliqopa (copanlisib)
    2ms
    CRUKD/17/009: BT1718 in Patients With Advanced Solid Tumours. (clinicaltrials.gov)
    P1/2, N=72, Completed, Cancer Research UK | Active, not recruiting --> Completed
    Trial completion
    |
    MMP14 (Matrix Metallopeptidase 14)
    |
    BT1718
    2ms
    Sacituzumab govitecan (SG) + pembrolizumab (pembro) in first-line (1L) metastatic non-small cell lung cancer (mNSCLC): Efficacy results by histology from the EVOKE-02 study (ELCC 2024)
    Conclusions In EVOKE-02, SG + pembro showed promising activity regardless of histology (squamous and nonsquamous) in previously untreated mNSCLC. The safety profile was manageable and consistent with the known safety profile of each agent.
    Clinical • Metastases
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • Trodelvy (sacituzumab govitecan-hziy)
    2ms
    CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=38, Active, not recruiting, Alliance Foundation Trials, LLC. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • Imfinzi (durvalumab) • docetaxel
    3ms
    First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small-cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial. (PubMed, Lancet Respir Med)
    Penpulimab plus chemotherapy significantly improved progression-free survival in patients with advanced squamous non-small-cell lung cancer compared with chemotherapy alone. The treatment was safe and tolerable. Penpulimab combined with paclitaxel and carboplatin is a new option for first-line treatment in patients with this advanced disease.
    P3 data • Journal • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    carboplatin • paclitaxel • Anniko (penpulimab)
    3ms
    A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension (clinicaltrials.gov)
    P3, N=339, Recruiting, Merck Sharp & Dohme LLC
    New P3 trial • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed