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CompletedLast updated: 2 February 2024

CINC280: This phase II trial is evaluating the use of two targeted therapies (Capmatinib and Pembrolizumab) in comparison to one targeted therapy (Pembrolizumab) to treat locally advanced or metastatic non-small cell lung cancerA randomised, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumb versus pembrolizumab alone as a first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1 ≥ 50%

Clinical summary

Summary

For patients to be eligible to participate in this trial the non-small cell carcinoma needs to have PD-L1 expression of ≥ 50% and have no EGFR mutation or ALK rearrangement. Eligible patients will either receive oral tablets of Capmatinib to be taken twice per day and intravenous infusion of Pembrolizumab once every 3 weeks, or 3 weekly infusions of Pembroliumab only.

Conditions

This trial is treating patients with locally advanced or metastatic non-small cell lung cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

CINC280

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A randomised, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumb versus pembrolizumab alone as a first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1 ≥ 50%

Eligibility

Inclusion

  • Histologically confirmed and documented locally advanced stage III (not candidates for surgical resection or definitive chemo-radiation) or stage IV (metastatic) NSCLC (per AJCC/IASLC v.8) for treatment in the first-line setting
  • Histologically or cytologically confirmed diagnosis of NSCLC that is both EGFR wild type status and ALK- negative rearrangement statu
  • Have an archival tumor sample or newly obtained tumor biopsy with high PD-L1 expression (TPS ≥ 50%)
  • ECOG performance status score ≤ 1
  • Have at least 1 measurable lesion by RECIST 1.1
  • Have adequate organ function

Exclusion

  • Prior treatment with a MET inhibitor or HGF-targeting therapy
  • Prior immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
  • Have untreated symptomatic central nervous system (CNS) metastases
  • Clinically significant, uncontrolled heart diseases
  • Prior palliative radiotherapy for bone lesions ≤ 2 weeks prior to starting study treatment

Other protocol-defined inclusion/exclusion criteria may apply.

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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