Clinical trial · Interventional
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell 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)
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.
Conditions
Conditions (1)
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 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| CP-751,871 | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CP-751,871 + Gemcitabine + Cisplatin
- description
- investigational arm
- interventionNames
- Drug: CP-751,871
- Drug: Cisplatin
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Gemcitabine + Cisplatin
- description
- standard of care
- interventionNames
- Drug: Cisplatin
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive * Male or female \> 18 years * Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1 * Adequate organ function Exclusion Criteria: * Uncontrolled hypertension or diabetes; * Pregnant female; * Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
References
Publications (0)
Data not yet available