Clinical trial · Interventional
Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations
Phase II Pilot Study Evaluating Strategies to Overcome Resistance at the Time of Progression for Patients With Non-small Cell Lung Cancers Harboring Major Oncogenic Drivers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual, closed by IRB
Summary
Brief summary (as posted)
This phase II trial studies how well targeted therapy works in treating patients with incurable non-small cell lung cancer with a genetic mutation. Giving drugs that target other genetic mutations or other specific proteins may work better when a patient has cancer caused by a driver mutation and the treatment that targets that mutation stops working.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Activating Mutation | — | UNRESOLVED | — |
| Recurrent Non-Small Cell Lung Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immunotherapy | Biological | Immunotherapy | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
| Targeted Molecular Therapy | Drug | — | UNRESOLVED |
| Tyrosine Kinase Inhibitor | Drug | Tyrosine Kinase Inhibitor | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (nivolumab, pembrolizumab)
- description
- Patients receive nivolumab IV over 60 minutes every 2 weeks or pembrolizumab IV every 3 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Biological: Nivolumab
- Biological: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Arm II (kinase inhibitor, chemotherapy, immunotherapy)
- description
- Patients receive tyrosine kinase inhibitor therapy PO targeting the initial oncogenic driver or other treatment for about 3 weeks.
- interventionNames
- Drug: Chemotherapy
- Biological: Immunotherapy
- Other: Laboratory Biomarker Analysis
- Drug: Tyrosine Kinase Inhibitor
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmed incurable non-small cell lung cancer that harbors an activating mutation in EGFR, MET, BRAF, V600E, RET, HER2, translocation in Alk, or translocation in ROS-1 * Patients must be receiving treatment or planning to start treatment with a tyrosine kinase inhibitor targeting the activated gene * Patients may not be receiving the treatment targeting the activated gene as part of a clinical treatment trial other than the Precision Oncology Trial * Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 * Total bilirubin =\< 1.5 X institutional upper limit of normal * Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine transaminase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document Exclusion Criteria: * Emergent need for palliative radiation * Patients may not be receiving any other investigational agents for the treatment of non-small cell lung cancer * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded; breastfeeding should be discontinued
References
Publications (0)
Data not yet available