Clinical trial · Interventional
An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
An Exploratory Study on Anti-tumour Activity of Orally Administered RO4929097, a Gamma-secretase Inhibitor, as a Single Agent in Patients With Recurrent or Refractory 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 study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is \<50.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO4929097 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cohort 1
- interventionNames
- Drug: RO4929097
- type
- EXPERIMENTAL
- label
- cohort 2
- interventionNames
- Drug: RO4929097
Primary outcomes (1)
- measure
- Tumour blood flow and tumour metabolic response rate
- timeFrame
- PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)
Secondary outcomes (3)
- measure
- Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients, \>/= 18 years of age * stage IIIB/IV recurrent or refractory non-small cell lung cancer * at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy) * ECOG performance status 0-2 * adequate liver, renal and bone marrow function Exclusion Criteria: * prior chemotherapy or radiotherapy \</= 4 weeks before first dose of study drug * history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma * history of CNS metastases or leptomeningeal metastases, except for clinically stable disease * serious cardiovascular illness
References
Publications (0)
Data not yet available