Clinical trial · Interventional
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
- 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 open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.
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 | Drug | Cisplatin | ALIAS |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| RO5083945 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A non-squamous
- interventionNames
- Drug: RO5083945
- Drug: cisplatin
- Drug: pemetrexed
- type
- EXPERIMENTAL
- label
- A squamous
- interventionNames
- Drug: RO5083945
- Drug: cisplatin
- Drug: gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- B non-squamous
- interventionNames
- Drug: cisplatin
- Drug: pemetrexed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/=18 years of age * Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer * At least 1 measurable disease lesion as per RECIST criteria * Confirmed presence of EGFR in tumor tissue * ECOG performance status 0-1 * Adequate hematological, renal and liver function Exclusion Criteria: * Prior chemotherapy or treatment with another systemic anti-cancer agent * Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief * Symptomatic or active CNS metastases * Recent history of poorly controlled hypertension (systolic \>180mmHg or diastolic \>100mmHg) * Requirement for steroids \> 40 mg prednisolone
References
Publications (0)
Data not yet available