A Study Evaluating RO5479599 in Combination With Carboplatin and Paclitaxel in Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) of Squamous Histology

NCT ID: NCT02204345

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

Brief Summary

A multi-center Phase Ib/II study of the combination of RO5479599 with carboplatin and paclitaxel once in every 3 week (q3w) regimen to evaluate the safety and tolerability.

Conditions

Squamous Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RO5479599 + Carboplatin + Paclitaxel

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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

RO5479599

Intervention Type: DRUG

RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

Carboplatin

Intervention Type: DRUG

Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.

Interventions

Paclitaxel

Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

Intervention Type: DRUG

RO5479599

RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.

Intervention Type: DRUG

Carboplatin

Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Toronto, Ontario, Canada

København Ø, , Denmark

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Madrid, Madrid, Spain

Valencia, Valencia, Spain

Countries

Canada; Denmark; Spain

Other Identifiers

2014-001498-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP29360

Identifier Type: -

Identifier Source: org_study_id