Clinical trial · Interventional
A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
An Open-label, Multicenter, Randomized, Phase 2 Study of a Recombinant Human Anti-VEGFR-2 Monoclonal Antibody, IMC-1121B in Combination With Platinum-based Chemotherapy Versus Platinum-based Chemotherapy Alone as First-line Treatment of Patients With Recurrent or Advanced Non-small Cell Lung Cancer (NSCLC)
- 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)
The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin (AUC 5) | Drug | Carboplatin | ALIAS |
| Carboplatin (AUC 6) | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| IMC-1121B (ramucirumab) | Biological | Ramucirumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- IMC-1121B + Pemetrexed + Carboplatin (AUC 6) or Cisplatin
- description
- IMC-1121B + Pemetrexed + Carboplatin \[Area Under the Concentration Time Curve 6 (AUC 6)\] or Cisplatin
- interventionNames
- Biological: IMC-1121B (ramucirumab)
- Drug: Pemetrexed
- Drug: Carboplatin (AUC 6)
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Pemetrexed + Carboplatin (AUC 6) or Cisplatin
- description
- Pemetrexed + Carboplatin (AUC 6) or Cisplatin
- interventionNames
- Drug: Pemetrexed
- Drug: Carboplatin (AUC 6)
- Drug: Cisplatin
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed NSCLC * Stage IV disease at the time of study entry * Measurable disease at the time of study entry * Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia) * Adequate hematologic function, hepatic function, renal function and coagulation function * If sexually active, must be post-menopausal, surgically sterile, or using effective contraception; and agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication * Female participants of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: * Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis * Tumor wholly or partially contains small cell lung cancer * Untreated central nervous system (CNS) metastases, eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to randomization * Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years * Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) * Receiving concurrent treatment with other anticancer therapy * Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization) * Has radiologically documented evidence of major blood vessel invasion or encasement by cancer * Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions) * Ongoing or active infection * History of significant neurological or psychiatric disorders * Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia * Poorly-controlled hypertension * Experienced any serious Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry * Receiving chronic daily treatment with aspirin (\> 325 mg/day) or other known inhibitors of platelet function * Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization * Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization * Elective or a planned major surgery * Pregnant or lactating * Any other serious uncontrolled medical disorders or psychological conditions * Allergy / history of hypersensitivity reaction to any of the treatment components * History of drug abuse
References
Publications (1)
- DERIVEDDoebele RC, Spigel D, Tehfe M, Thomas S, Reck M, Verma S, Eakle J, Bustin F, Goldschmidt J Jr, Cao D, Alexandris E, Yurasov S, Camidge DR, Bonomi P. Phase 2, randomized, open-label study of ramucirumab in combination with first-line pemetrexed and platinum chemotherapy in patients with nonsquamous, advanced/metastatic non-small cell lung cancer. Cancer. 2015 Mar 15;121(6):883-92. doi: 10.1002/cncr.29132. Epub 2014 Nov 6. PMID 25377507