Clinical trial · Interventional
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer
A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (Metmab) in Combination With Paclitaxel + Cisplatin or Carboplatin as First-Line Treatment for Patients With Stage IIIb (T4 Disease) or IV Squamous 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)
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.
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 |
|---|---|---|---|
| Non-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin/carboplatin | Drug | — | UNRESOLVED |
| onartuzumab | Drug | Onartuzumab | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MetMAb+paclitaxel+platinum
- interventionNames
- Drug: cisplatin/carboplatin
- Drug: onartuzumab
- Drug: paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Placebo+paclitaxel+platinum
- interventionNames
- Drug: Placebo
- Drug: cisplatin/carboplatin
- Drug: paclitaxel
Primary outcomes (2)
- measure
- Progression-free survival (tumor assessments according to RECIST criteria)
- timeFrame
- up to approximately 32 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * No prior chemotherapy for squamous NSCLC * Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown * Radiographic evidence of disease Exclusion Criteria: * Prior systemic treatment for Stage IIIB or IV squamous NSCLC * NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS) * Prior exposure to experimental treatment targeting either the HGF or Met pathway * Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator * Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1 * History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer * Pregnant or lactating women * Uncontrolled diabetes * Impaired bone marrow, liver or renal function as defined by protocol * Significant history of cardiovascular disease * Positive for HIV infection
References
Publications (0)
Data not yet available