Clinical trial · Interventional
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer
- 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)
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
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 |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
- interventionNames
- Drug: Ipilimumab
- Drug: Placebo
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
- interventionNames
- Drug: Ipilimumab
- Drug: Placebo
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Ipilimumab placebo + paclitaxel + carboplatin
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\]) * Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria * Eastern Cooperative Oncology Group performance status of ≤1 at study entry * Accessible for treatment and follow-up Exclusion Criteria: * Brain metastases * Malignant pleural effusion * Autoimmune disease * Motor neuropathy of autoimmune origin * SCLC-related paraneoplastic syndromes * Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study) * Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed. * Grade 2 peripheral neuropathy (motor or sensory) * Known HIV or hepatitis B or C infection * Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies. * Inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dL. * Inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present. * Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN * Inadequate creatinine clearance defined as less than 50 mL/min.
References
Publications (0)
Data not yet available