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

Roche

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: RO5479599; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02204345

BP29360

2014-001498-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

RO5479599 + Carboplatin + Paclitaxel

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: RO5479599

Drug: Paclitaxel