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Phase 2 N=160 Randomized Treatment

Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer

Extensive Stage Lung Small Cell Carcinoma · Recurrent Lung Small Cell Carcinoma

Enrolled (actual)
160
Serious AEs
71.5%
Results posted
Jun 2023
Primary outcome: Primary: Progression-free Survival (PFS) — 5.5; 4.9 months — p=0.17

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Carboplatin (Drug); Cisplatin (Drug); Etoposide (Drug); Nivolumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Feb 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-free Survival (PFS)
5.5; 4.9 0.17
SECONDARY
Overall Survival (OS)
11.2; 8.1
SECONDARY
Response Rate
0.77; 0.80

Summary

This randomized phase II clinical trial studies whether the addition of nivolumab to cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients with extensive stage small cell lung cancer. Chemotherapy drugs, such as cisplatin, carboplatin, and etoposide, 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. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cisplatin/carboplatin and etoposide together with nivolumab may work better in treating patients with extensive stage small cell lung cancer.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed extensive stage small cell lung cancer and must be a candidate for systemic therapy; NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy; patients with locally recurrent SCLC who are not eligible for curative intent chemoradiation are eligible
  • Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Absolute neutrophil count >= 1, 500/mm^3 (must be obtained = = 100,000/mm^3 (must be obtained = = 3000/mm^3 (must be obtained = = 9 g/dL (must be obtained = 50 mL/min (using the Cockcroft-Gault formula) (must be obtained = 10 mg daily prednisone equivalent) or other immunosuppressive medications within 7 days of randomization; inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • No patients with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • No history of severe hypersensitivity reaction to any monoclonal antibody or allergy to study drug components

Exclusion Criteria

  • Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or other agents used in the study
  • Women must not be pregnant or breast-feeding; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding must be discontinued or the subject is not eligible for the study; all females of childbearing potential must have a blood test or urine study, with a minimum sensitivity 50 mlU/L or equivalent units of human chorionic gonadotropin (HCG), within 14 days prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months)
  • Patient must not have leptomeningeal disease
  • Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection, patients are excluded
  • Patients are ineligible if they received a live, attenuated vaccine within 4 weeks before randomization
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03382561). 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.

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