A Study Evaluating RO5479599 in Combination With Carbopla... | NCT02204345

ID	Type	Description	Link
2014-001498-15	EudraCT Number

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RO5479599 + Carboplatin + Paclitaxel	Experimental	RO5479599 800 milligrams (mg) will be administered in the Safety Run-In Phase by intravenous infusion q3w on Day 1 of 3-weekly cycles (each cycle of 21 days) in combination with carboplatin (to produce an area under the curve [AUC] of 6 mg/milliliter [mL]*minute) and paclitaxel 200 mg per square meter (mg/m^2) by intravenous infusion q3w for 4 to 6 cycles. Thereafter, RO5479599 will be continued as a monotherapy (carboplatin and paclitaxel may be continued at the investigator's discretion) until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.	Drug: Carboplatin Drug: Paclitaxel Drug: RO5479599

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carboplatin	Drug	Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.	RO5479599 + Carboplatin + Paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Adverse Events		Baseline up to Day 342
Percentage of Participants With Objective Response as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)		Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) as Assessed Using RECIST v1.1		Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first (assessed every 6 weeks from baseline [Cycle 1 Day 1] [Cycle length = 21 days] up to Day 342)
Overall survival (OS)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Locally advanced or metastatic (stage IIIB or IV) squamous NSCLC
No prior systemic chemotherapy, targeted therapy for metastatic NSCLC
Evidence of at least one radiologically measurable lesion as per RECIST version 1.1
Adequate hematological, liver and renal function
Participants must agree to either remain completely abstinent or to use effective contraceptive methods from screening until 6 months after the last dose of study treatment
Histologically confirmed squamous NSCLC participants eligible for enrollment must provide archival tumor biopsy tissue or if unavailable must be willing to undergo a fresh pretreatment primary tumor or metastatic biopsy
Participants with Gilbert's Syndrome will be eligible for the study

Exclusion Criteria:

Concurrent therapy with any other investigational drug
History or clinical evidence of central nervous system (CNS) primary tumors or metastases
Evidence of significant, uncontrolled concomitant diseases, which could affect compliance with the protocol or interpretation of results, including uncontrolled diabetes mellitus and/or significant cardiovascular disease or uncontrolled infection
Any other diseases, metabolic dysfunction, a physical examination finding or a clinical laboratory finding, giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
Major surgery or significant traumatic injury less than (<) 28 days prior to the first study treatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment
Pregnant or breast-feeding women
History of other malignancies that could affect compliance with protocol or interpretation of results. Participants with malignancies diagnosed more than 5 years prior to study day one, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer are generally eligible

Facility	Status	City	State	ZIP	Country	Contacts
		Toronto	Ontario	M5G 2M9	Canada