A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab as first line therapy for locally advanced or metastatic non-squamous and squamous non-small cell lung cancer subjects (CANOPY-1)

Conditions

Non-small cell lung cancer

Brief summary

Safety run-in part: Incidence of dose limiting toxicities in the first 42 days of study treatment., Double-blind, randomized, placebo-controlled part: PFS based on local investigator assessment as per RECIST 1.1, Double-blind, randomized, placebo-controlled part: OS

Detailed description

Safety run-in part: 1. Concentration and PK parameters of canakinumab, pembrolizumab and chemotherapy, Safety run-in part: 2. Type, frequency and severity of adverse events and reactions, changes in laboratory values, vital signs, ECGs, Safety run-in part: 3. ORR, DCR, DOR by investigator's assessment according to RECIST 1.1, Safety run-in part: 4. Anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment of canakinumab and pembrolizumab, Double-blind, randomized, placebo-controlled part: 1. ORR, DCR, TTR and DOR based on local investigator assessment as per RECIST 1.1, Double-blind, randomized, placebo-controlled part: 2. Frequency of adverse events, serious adverse events, AEs leading to treatment discontinuation, proportion of patients with laboratory abnormalities, ECG, and vital signs., Double-blind, randomized, placebo-controlled part: 3. Concentration and PK parameters of canakinumab, pembrolizumab and chemotherapy, Double-blind, randomized, placebo-controlled part: 4. Anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment of canakinumab and pembrolizumab, Double-blind, randomized, placebo-controlled part: 5. Time to definitive 10-point deterioration symptom scores for chest pain, cough and dyspnea per QLQ-LC13 questionnaire as three primary PRO variables of interest and time to definitive deterioration in global health status/QoL, shortness of breath and pain per QLQ-C30 as secondary PRO variables of interest.

Related papers

No related papers found yet.

Interventions

DRUGCANAKINUMAB

DRUGPEMETREXED

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety run-in part: Incidence of dose limiting toxicities in the first 42 days of study treatment., Double-blind, randomized, placebo-controlled part: PFS based on local investigator assessment as per RECIST 1.1, Double-blind, randomized, placebo-controlled part: OS	—

Secondary

Measure	Time frame
Safety run-in part: 1. Concentration and PK parameters of canakinumab, pembrolizumab and chemotherapy, Safety run-in part: 2. Type, frequency and severity of adverse events and reactions, changes in laboratory values, vital signs, ECGs, Safety run-in part: 3. ORR, DCR, DOR by investigator's assessment according to RECIST 1.1, Safety run-in part: 4. Anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment of canakinumab and pembrolizumab, Double-blind, randomized, placebo-controlled part: 1. ORR, DCR, TTR and DOR based on local investigator assessment as per RECIST 1.1, Double-blind, randomized, placebo-controlled part: 2. Frequency of adverse events, serious adverse events, AEs leading to treatment discontinuation, proportion of patients with laboratory abnormalities, ECG, and vital signs., Double-blind, randomized, placebo-controlled part: 3. Concentration and PK parameters of canakinumab, pembrolizumab and chemotherapy, Double-blind, randomized, placebo-contro	—

Measure

Time frame

Safety run-in part: 1. Concentration and PK parameters of canakinumab, pembrolizumab and chemotherapy, Safety run-in part: 2. Type, frequency and severity of adverse events and reactions, changes in laboratory values, vital signs, ECGs, Safety run-in part: 3. ORR, DCR, DOR by investigator's assessment according to RECIST 1.1, Safety run-in part: 4. Anti-drug antibodies (ADA) prevalence at baseline and ADA incidence on-treatment of canakinumab and pembrolizumab, Double-blind, randomized, placebo-controlled part: 1. ORR, DCR, TTR and DOR based on local investigator assessment as per RECIST 1.1, Double-blind, randomized, placebo-controlled part: 2. Frequency of adverse events, serious adverse events, AEs leading to treatment discontinuation, proportion of patients with laboratory abnormalities, ECG, and vital signs., Double-blind, randomized, placebo-controlled part: 3. Concentration and PK parameters of canakinumab, pembrolizumab and chemotherapy, Double-blind, randomized, placebo-contro

—

Countries

Germany, Spain

Outcome results

None listed