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Closed (no longer recruiting)Last updated: 21 December 2023

Javelin Lung 101: This phase I/II trial is evaluating the safety and effictiveness of avelumab (an immunotherapy drug) when it is combined with one of two anti-cancer drugs (crizotinib or PF-06463922) for the treatment of Non Small Cell (NSC) Lung CancerA Phase 1b/2, Open-Label, Dose-Finding Study To Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab (MSB0010718C) In Combination With Either Crizotinib Or PF-06463922 In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer

Clinical summary

Summary

The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18 - 75

Phase

I/II

Trial Acronym

Javelin Lung 101

More information

Trial Identifiers

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Trial sponsor

Pfizer

Scientific Title

A Phase 1b/2, Open-Label, Dose-Finding Study To Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab (MSB0010718C) In Combination With Either Crizotinib Or PF-06463922 In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • Inclusion Criteria
  • Diagnosis of advanced or metastatic NSCLC. Group A must be ALK negative NSCLC and Group B must be ALK positive NSCLC
  • Group A at least one prior regimen of therapy
  • Group B any number of prior regimens.
  • Mandatory tumor tissue available
  • At least one measurable lesion
  • ECOG Performance status 0 or 1
  • Adequate bone marrow, renal, liver and pancreatic function
  • Negative pregnancy test for females of childbearing potential
  • Group B Phase 2: No prior systemic treatment for advanced or metastatic disease (adjuvant and/or neoadjuvant therapies are allowed if completed at least 6 months prior to study entry. No prior tyrosine kinase inhibitor therapy is allowed at any time prior to study entry)

Exclusion

  • No prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody.
  • No Severe or Chronic medical conditions including gastrointestinal abnormalities or significant cardiac history
  • No active infection requiring systemic therapy
  • Prior organ transplantation including allogenic stem cell transplantation.

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.

Exclusion

  • 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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