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An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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).

NCT01070927•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Amsterdam, Netherlands

Key Dates

Start Date

January 1, 2010

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

November 2, 2016

Enrollment

ACTUAL participants

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

RO4929097

DRUG

RO4929097

DRUG

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

NCT06627647

Non-squamous Non-small Cell Lung Cancer

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RECRUITINGPHASE2/PHASE3

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

NCT06417008

Non-Squamous Non-Small Cell Lung Cancer

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ACTIVE_NOT_RECRUITINGPHASE3

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC

A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Paclitaxel-bevacizumab in Advanced Lung Cancer

A Study of TQB2450 Injection Plus Chemotherapy Followed by TQB2450 Plus Anlotinib Versus Tislelizumab Plus Chemotherapy Followed by Tislelizumab in the Treatment of First-line Non-squamous Non-small Cell Lung Cancer(NSCLC).