Clinical trial · Interventional
Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the Investigational treatments have been moved to a continuation study (NCT05059522)
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of avelumab when combined with either crizotinib or PF-06463922.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
| Crizotinib | Drug | Crizotinib | ALIAS |
| PF-06463922 | Drug | Lorlatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- ALK negative Non-Small Cell Lung Cancer
- interventionNames
- Drug: Avelumab
- Drug: Crizotinib
- type
- EXPERIMENTAL
- label
- Group B
- description
- ALK positive Non-Small Cell Lung Cancer
- interventionNames
- Drug: Avelumab
- Drug: PF-06463922
Primary outcomes (3)
- measure
- Number of Participants With Dose-limiting Toxicities (DLTs): Phase 1b
- timeFrame
- First 2 cycles (1 cycle = 14 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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 Criteria: * 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.
References
Publications (1)
- DERIVEDSolomon BJ, Dagogo-Jack I, Lee SH, Boyer MJ, Ramalingam SS, Carcereny E, Felip E, Han JY, Hida T, Hughes BGM, Kim SW, Nishio M, Seto T, Okamoto T, Zhang X, Martini JF, Wang E, De Beukelaer S, Bauer TM. Avelumab in Combination With Lorlatinib or Crizotinib in Patients With Previously Treated Advanced NSCLC: Phase 1b/2 Results From the JAVELIN Lung 101 Trial. JTO Clin Res Rep. 2024 May 16;5(7):100685. doi: 10.1016/j.jtocrr.2024.100685. eCollection 2024 Jul. PMID 39034968