Clinical trial · Interventional
MK-3475 and Gemcitabine in Non-Small Cell Lung Cancer (NSCLC)
A Phase I/II Study of MK-3475 With Gemcitabine in Patients With Previously-Treated Advanced Non-small Cell Lung Cancer (NSCLC)
NCT02422381CI-TRIAL-00103552active not recruitingPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study for patients with previously-treated advanced non-small cell lung cancer (NSCLC). The study will evaluate the safety of adding an investigational drug, MK-3475 to standard treatment with gemcitabine. The study will also try to identify the best dose of MK-3475 to give in combination with gemcitabine.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| MK-3475 | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MK-3475 + Gemcitabine
- description
- 200mg MK-3475 200 given by IV infusion every 3 weeks, for 2 years, or until disease progression and Gemcitabine 1250 mg/m2 iv Days 1, 8 every 3 weeks, for maximum 6 cycles.
- interventionNames
- Drug: MK-3475
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Dose Limiting Toxicities
- timeFrame
- 126 Days (six 21-day cycles)
- description
- Patients are seen in clinic 12 times over 126 days to determine any changes in signs or symptoms that may represent drug toxicity. Drug toxicity is defined as events that required holding or delaying treatment.
Secondary outcomes (3)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women or men with advanced, histologically proven NSCLC. * Patients must have received at least one but no more than three prior systemic therapies for advanced disease. * Any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with anti-PD1 therapy or gemcitabine should be resolved to less than Grade 1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Women of childbearing potential must have a negative pregnancy test * Ability to give informed consent and comply with the protocol. * Anticipated survival minimum 3 months. * Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment. * Patients must have normal organ and marrow function as seen on protocol-defined blood test results * Archived tumor tissue (minimum of 8 slides for paraffin-embedded tumor tissue) available * Measurable disease by RECIST 1.1 criteria. * Treated brain metastases will be allowed, provided they are asymptomatic. * Radiation for symptomatic lesions outside the Central nervous system (CNS) must have been completed at least 2 weeks prior to study enrollment. Exclusion Criteria: * Prior therapy with any anti-PD-1, anti-PD-L1, or anti-CTLA4 antibody. * Prior therapy with gemcitabine. * Prior complications from radiation, such as history of radiation pneumonitis or pulmonary edema that, in the opinion of the investigator, may have risk of increasing toxicity with anti-PD1 therapy. * Active autoimmune disease except vitiligo or stable hypothyroidism. * Active and ongoing steroid use, except for non-systemically absorbed treatments (such as inhaled or topical steroid therapy for asthma, cardiopulmonary disease (COPD), allergic rhinitis). * Active other malignancy, except for controlled basal cell skin carcinoma. * HIV positive and/or Hepatitis B or C positive. * Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in this protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.