Clinical trial · Interventional
MK-0646, Etoposide, and Cisplatin in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination With Etoposide and Cisplatin in Extensive Stage 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)
RATIONALE: Monoclonal antibodies, such as MK-0646, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I/II trial is studying the side effects and best dose of MK-0646 when given together with etoposide and cisplatin and to see how well it works in treating patients with extensive-stage small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- MK-0646, a monoclonial antibody in combination with etoposide and cisplatin.
- interventionNames
- Biological: anti-IGF-1R recombinant monoclonal antibody MK-0646
- Drug: cisplatin
- Drug: etoposide
Primary outcomes (5)
- measure
- Recommended phase II dose of MK-0646 in combination with standard etoposide and cisplatin chemotherapy
- timeFrame
- Each dose level
- description
- Evaluate safety, tolerability in combination with standard chemotherapy.
- measure
- Toxicity and tolerability according to NCI CTCAE v3.0
- timeFrame
- Phase 1, each dose level and Phase II
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer (SCLC) * Extensive stage disease that is incurable but amenable to treatment with platinum-based chemotherapy * Small cell and variant histologies allowed * No mixed tumors (i.e., small and large cell) or other neuroendocrine tumors of the lung * Clinically and/or radiologically documented measurable disease, defined as ≥ 1 unidimensionally measurable site of disease ≥ 20 mm by chest x-ray, ≥ 15 mm by CT scan (lymph nodes), or ≥ 10 mm by CT scan or physical exam * No uncontrolled or symptomatic CNS metastases * Patients who have completed radiotherapy or have undergone complete resection of CNS metastases are allowed provided they are on stable (non-increasing) or decreasing doses of corticosteroids PATIENT CHARACTERISTICS: * Life expectancy ≥ 12 weeks * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin ≤ upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN (≤ 5 times ULN if documented liver metastases) * Serum creatinine ≤ ULN OR creatinine clearance ≥ 50 mL/min * Not pregnant or lactating * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after completion of study therapy * No other active cancer * No untreated and/or uncontrolled cardiovascular or other comorbid conditions * Patients with a significant cardiac history, even if controlled, should have a LVEF \> 50% * No uncontrolled diabetes * Must be accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior cytotoxic chemotherapy or other IGF-1R targeting agents for SCLC * At least 3 weeks since prior radiotherapy to neurological sites * No prior radiotherapy to the lungs * Prior surgery allowed provided that wound healing has occurred * At least 14 days since prior major surgery * No other concurrent investigational agents or therapy * No other concurrent anticancer treatment * No concurrent radiotherapy
References
Publications (2)
- RESULTJ Clin Oncol 30, 2012 (suppl; abstr 7093)
- RESULTEllis PM, Shepherd FA, Laurie SA, Goss GD, Olivo M, Powers J, Seymour L, Bradbury PA. NCIC CTG IND.190 phase I trial of dalotuzumab (MK-0646) in combination with cisplatin and etoposide in extensive-stage small-cell lung cancer. J Thorac Oncol. 2014 Mar;9(3):410-3. doi: 10.1097/JTO.0000000000000058. PMID 24518092