Phase 1
N=73
Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer
Extensive Stage Small Cell Lung Carcinoma · Limited Stage Small Cell Lung Carcinoma · Neuroendocrine Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT02402920 ↗Enrolled (actual)
73
Serious AEs
10.0%
Results posted
Mar 2026
Primary outcome: Primary: Dose Limiting Toxicity (DLT) — 1; 0 Count of DLTs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Carboplatin (Drug); Cisplatin (Drug); Etoposide (Drug); Laboratory Biomarker Analysis (Other); Pembrolizumab (Biological); Radiation Therapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Dec 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity (DLT) |
1; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
19.7; 6.1 | — |
| SECONDARY Overall Survival |
39.5; 8.4 | — |
| SECONDARY Overall Response Rate (ORR) |
79; 15.20 | — |
Summary
This phase I trial studies the side effects and best dose of pembrolizumab when given together with chemoradiotherapy or radiation therapy in treating patients with small cell lung cancer. 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. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more cancer cells. Giving pembrolizumab with chemoradiotherapy or radiation therapy may be a better treatment for small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written informed consent/assent for the trial
- Have a performance status of 0 or 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- Absolute neutrophil count (ANC) >= 1, 500/mcL (performed within 10 days of treatment initiation)
- Platelets >= 100, 000/mcL (performed within 10 days of treatment initiation)
- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L (performed within 10 days of treatment initiation)
- Serum creatinine or measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) = = 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (creatinine clearance should be calculated per institutional standard) (performed within 10 days of treatment initiation)
- Serum total bilirubin = 1.5 ULN (performed within 10 days of treatment initiation)
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamate pyruvate transaminase (SGPT) = 1 year
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
- Histologic diagnosis of either limited stage SCLC (LS-SCLC), or extensive stage SCLC (ES-SCLC) or neuroendocrine tumor
Exclusion Criteria
- Is currently participating in or has participated in a study of an investigational agent (except glutamine) or using an investigational device within 2 weeks of the first dose of treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment; with the exception of physiologic steroid replacement
- Has had a prior monoclonal antibody within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
- Has had prior chemotherapy, targeted small molecule therapy, within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent; prior radiation does not require a washout period; note: subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study; note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
- Has a known additional malignancy that is progressing or requires active treatment; exceptions include skin basal cell carcinoma (basal cell carcinoma of the skin), skin squamous cell carcinoma (squamous cell carcinoma of the skin), or in situ cervical cancer that has undergone potentially curative therapy
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule; subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study; subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study
- Has evidence of interstitial lung disease or active, n
Data sourced from ClinicalTrials.gov (NCT02402920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.