Testing the Effects of MK-3475 (Pembrolizumab) With or Without the Usual Chemotherapy Treatment for Patients 70 Years of Age and Older With Advanced Non-small Cell Lung Cancer
This study evaluates the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back after a period of improvement (recurrent) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 4 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 8, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Other: Comprehensive Geriatric Assessment; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Documentation of Disease: Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation
- Planning to begin MK-3475 (pembrolizumab) treatment within 14 days of registration, with or without combination chemotherapy. Treating physician considers pembrolizumab as appropriate and plans to proceed with one of the following treatment schedules:
- MK-3475 (pembrolizumab) 200 mg IV flat dose every 21 days or 400 mg IV flat dose every 42 days.
- MK-3475 (pembrolizumab) 200 mg IV/ 400 mg IV + carboplatin area under the curve (AUC) = 5 + pemetrexed 500 mg/m\^2 (20% chemotherapy dose reduction is permitted per the discretion of the treating physician)
- Patients will be ineligible if they are post-organ transplantation, or are receiving ongoing immunosuppression treatment. Patients will be ineligible if they have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) \
- Note: Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients who require inhaled corticosteroids would not be excluded from the study. Patients with vitiligo or resolved childhood asthma/atopy would not be excluded from the study. Patients who require local steroid injections (for example, a steroid injection to a joint) would not be excluded from the study.
- Prior adjuvant therapy is allowed and must have been completed at least 6 months prior to registration
- No planned radiation or other cancer treatment in the 3 months following registration
- No untreated brain metastases. Patients must be off oral and IV corticosteroids for this condition and asymptomatic at registration
- Age \>= 70 years of age
- Absolute neutrophil count (ANC) \>= 1500/mm\^3 (1.5 x 10\^9/L)
- Platelet count: \>= 100,000/mm\^3 (100 x 10\^9/L)
- Calculated creatinine clearance \>= 30 mL/min\
- for patients enrolled to pembrolizumab alone and \> 45 mL/min for patients enrolled to chemotherapy + pembrolizumab \
- Calculated using the Cockcroft-Gault formula
- Total bilirubin =\< 1.5 upper limit of normal (ULN) (\< 3 ULN if Gilbert's disease)
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 3 x ULN (=\< 5.0 x ULN if liver metastases present)
- Alkaline phosphatase =\< 2.5 x ULN (=\< 5 x ULN if bone or liver metastases present) Language: Patients must be able to speak and comprehend English in order to complete the mandatory patient-completed measures
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska
- Anchorage Oncology CentreAnchorage, Alaska
- Katmai Oncology GroupAnchorage, Alaska
- Providence Alaska Medical CenterAnchorage, Alaska
- Fairbanks Memorial HospitalFairbanks, Alaska
- Kingman Regional Medical CenterKingman, Arizona
- Mission Hope Medical Oncology - Arroyo GrandeArroyo Grande, California
- PCR OncologyArroyo Grande, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2026. Always confirm current availability with the study team.