Phase 2
N=331
Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)
Lung Cancer · Small Cell Lung Cancer · Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00527735 ↗Enrolled (actual)
331
Serious AEs
55.6%
Results posted
Jul 2012
Primary outcome: Primary: Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) — 5.52; 5.68; 4.63 Months — p=0.1302
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ipilimumab (Drug); Placebo (Drug); Paclitaxel (Drug); Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC) |
5.52; 5.68; 4.63 | 0.1302 |
| SECONDARY Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria |
4.11; 5.13; 4.21 | 0.2502 |
| SECONDARY Overall Survival in Participants With NSCLC |
9.69; 12.22; 8.28 | 0.4759 |
| SECONDARY Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC |
21.4; 32.4; 13.6; 32.6; 57.1; 48.9 | — |
| SECONDARY Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC) |
21.4; 32.4; 18.2; 48.8; 71.4; 53.3 | — |
| SECONDARY Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC |
70.0; 86.8; 81.8; 57.1; 77.9; 72.7 | — |
| SECONDARY Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC |
6.70; 5.55; 4.01; 5.42; 5.55; 4.01 | — |
| SECONDARY Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade |
52; 50; 51; 11; 7; 8 | — |
| SECONDARY Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade |
7.7; 6.2; 3.2; 90.8; 98.5; 90.2 | — |
| SECONDARY irPFS in Participants With SCLC Per irRC |
5.68; 6.44; 5.26 | 0.1098 |
| SECONDARY Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade |
24; 15; 19; 2; 4; 3 | — |
| SECONDARY Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade |
7.7; 6.2; 3.2; 1.5; 4.6; 1.6 | — |
| SECONDARY Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline |
2; 1 | — |
| SECONDARY Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade |
37; 31; 35; 6; 2; 1 | — |
| SECONDARY Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade |
7; 11; 13; 10; 9; 7 | — |
| SECONDARY Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade |
12; 12; 8; 2; 3; 1 | — |
| SECONDARY Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade |
7.7; 16.7; 11.6; 5.1; 4.8; 4.7 | — |
| SECONDARY Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria |
3.89; 5.22; 5.19 | 0.3846 |
| SECONDARY Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline |
2; 3; 2; 0 | — |
| SECONDARY Overall Survival in Participants With SCLC |
3.89; 5.22; 5.19 | 0.4132 |
Summary
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00527735). 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.