Primary outcomeMedian· Baseline until death, assessed monthly after end of treatment, up to 30 months
Overall Survival (OS)
| Group | Value (months) |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | 8.6 |
| Paclitaxel and Carboplatin (Chemo) | 9.8 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataCarboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
NCTNCT00596830 (opens ClinicalTrials.gov in a new tab)Other idA4021016
This trial was stopped early.
Reason given at the registry: See termination reason in detailed description.
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
- Measures IGF-1 (mecasermin), does not give it. It appears in an outcome measure.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 681 participants (actual)
- Sponsor
- Pfizer · Industry
- Design
- Randomized · Open label (no masking)
- Countries
26 countries
United States, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Poland, Puerto Rico, Russia, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), Ukraine
- Start
- Apr 2008
- Primary completion
- Mar 2011
- Completion
- Sept 2012
- First posted
- 17 Jan 2008 (estimated)
- Last update posted
- 13 Jan 2014 (estimated)
- Conditions
- Carcinoma, Squamous Cell · Carcinoma, Adenosquamous · Carcinoma, Large Cell · Carcinoma, Non-Small-Cell Lung
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010201120122013
- Ph 3Terminated
Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
NCT00596830Apr 2008 to Sept 2012
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.
Interventions
- CP-751,871 (Figitumumab)Drug
- CarboplatinDrug
- PaclitaxelDrug
- CarboplatinDrug
- PaclitaxelDrug
Arms2
Experimental
A
Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
Active comparator
B
Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
Primary outcomes1
Outcomes the sponsor listed as primary.
Overall Survival (OS)
Time frame · Baseline until death, assessed monthly after end of treatment, up to 30 months
Registry description
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
Secondary outcomes(9)
Progression-Free Survival (PFS)
Time frame · At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.
Registry description
PFS was defined as the time from randomization to first progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, with baseline and \>=1 on-study assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 (20% increase in the sum of target lesions' longest diameter over nadir, unequivocal progression of non-target disease, or appearance of new lesions).
Percentage of Participants With Objective Response (OR)
Time frame · At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months
Registry description
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response(PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR defined as complete disappearance of all target lesions and non-target disease. No new lesons. PR defined as ≥30% decrease under baseline of the sum of diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame · Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Registry description
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.
European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
Time frame · Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Registry description
QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
Time frame · Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Registry description
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range of -0.594 to 1; higher score indicates a better health state.
Maximum Observed Plasma Concentration (Cmax) for Figitumumab
Time frame · Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab
Time frame · Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Number of Participants With Total Anti-drug Antibodies (ADA)
Time frame · Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose
Registry description
ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.
Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels
Time frame · Cycles 1 and 4 (predose) and at end of treatment
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMedian· At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.
Progression-Free Survival (PFS)
| Group | Value (months) |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | 4.7 |
| Paclitaxel and Carboplatin (Chemo) | 4.6 |
Secondary outcomeNumber· At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months
Percentage of Participants With Objective Response (OR)
| Group | Value (percentage of participants) |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | 33.0 |
| Paclitaxel and Carboplatin (Chemo) | 34.5 |
Secondary outcome· Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
| Group | Value |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | not posted |
| Paclitaxel and Carboplatin (Chemo) | not posted |
Secondary outcome· Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score
| Group | Value |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | not posted |
| Paclitaxel and Carboplatin (Chemo) | not posted |
Secondary outcome· Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
| Group | Value |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | not posted |
| Paclitaxel and Carboplatin (Chemo) | not posted |
Secondary outcome· Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Maximum Observed Plasma Concentration (Cmax) for Figitumumab
| Group | Value |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | not posted |
Secondary outcome· Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose
Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab
| Group | Value |
|---|---|
| Figitumumab + Paclitaxel and Carboplatin | not posted |
| Paclitaxel and Carboplatin (Chemo) | not posted |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Figitumumab + Paclitaxel and CarboplatinFigitumumab (figi, \[CP-751, 871\]) was given in combination with paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression. | – | 223 / 338 | 316 / 338 |
| Paclitaxel and Carboplatin (Chemo)Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre \[mg/m\^2\]) and carboplatin (area under the concentration-time curve \[AUC\]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles. | – | 170 / 333 | 303 / 333 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedRoeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131. PMID 41332393
- DerivedRoeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11. PMID 38468440
- DerivedLanger CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2. PMID 24888810
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
* Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
* No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
* Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
* ECOG performance status (PS) 0 or 1.
Exclusion Criteria:
* Patients with symptomatic central nervous system (CNS) metastases are not permitted.
* Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
* Patients with other active cancer types are not permitted.
PepBank is a research reference. Talk to a doctor before you use any peptide.