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

NCT02204345 | Terminated Phase 1

• 2 other identifiers: BP293602014-001498-15
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 6

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

Outcome Measures

Primary Outcomes (2)

• 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 (14)

• 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)

  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)

• Percentage of Participants With Disease Control as Assessed by Investigator 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)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RO5479599

  Pre-dose(Hour 0); at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length= 21 days) up to end of treatment (EOT, Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4; at Day 342

• Maximum Observed Plasma Concentration (Cmax) of RO5479599

  Pre-dose (Hour 0) and at end of infusion (infusion duration=approximately 2 hours) on Day 1 of each cycle (cycle length= 21 days) up to EOT (Day 314); 3-6, 24, 72, 168, 264, 336, 432, 480 hours post-dose on Day 1 of Cycle 1,4; at Day 342

Study Arms (1)

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

Carboplatin DRUG

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

RO5479599 + Carboplatin + Paclitaxel

Paclitaxel DRUG

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

RO5479599 + Carboplatin + Paclitaxel

RO5479599 DRUG

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

RO5479599 + Carboplatin + Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

København Ø, 2100, Denmark

Location

Unknown Facility

Barcelona, Barcelona, 08003, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Madrid, Madrid, 28050, Spain

Location

Unknown Facility

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Interventions

Carboplatin; Paclitaxel; lumretuzumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 30, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

DK (1); ES (4); CA (1)