Efficacy of the anti-insulin like growth factor I receptor (IGF-IR) antibody CP-751871 in combination with paclitaxel and carboplatin as first-line treatment for advanced non-small cell lung cancer (NSCLC)
Bibliographic record
Abstract
7506 Background: CP-751871 is a fully human, IgG2 monoclonal antibody against the IGF-IR active in preclinical models of NSCLC. Methods: We are conducting a phase II, randomized, non-comparative study in ten centers to evaluate the safety and efficacy of combination paclitaxel (T), carboplatin (C) and CP-751871 (I) versus TC alone in stage IIIB, IV or recurrent, treatment-naive NSCLC pts with performance status 0–1. The statistical hypotheses are 28% (null) versus 40% (response of interest). Pts are randomized (2:1) to T (200 mg/m2), C (AUC of 6) and I (10 mg/kg), or TC alone every 3 weeks for up to 6 cycles; pts receiving TCI with response (PR) or stable disease following discontinuation of chemotherapy are eligible to continue I as single agent until disease progression. Pts progressing on TC alone are eligible to receive I as single agent or in combination with TC at the judgment of the investigator. Responses are assessed by investigator using RECIST. Results: An interim analysis for futility has been conducted with 73 pts enrolled: 48 treated with TCI; 25 with TC. TCI was well tolerated. All causality grade 3,4 toxicity included (TCI, TC): hyperglycemia (20%, 10%), fatigue (15%, 8%), neutropenia (13%, 20%) and neuropathy (10%, 4%). 22/48 pts receiving TCI (46%) and 8/32 pts on TC (32%) had objective responses. Furthermore, 14 out of 27 TCI pts (52%) with non-adenocarcinoma responded to treatment. In addition, a PR was observed in 1 out of 4 TC pts who elected to receive single agent I after progression on TC alone. Conclusions: CP-751871 appears safe in combination with TC. Interim TCI activity warranted further investigation. An additional 83 pts will be enrolled to assess further the safety and efficacy of this combination treatment. [Table: see text]
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".