Non-small Cell Lung CancerPhase 3CANOPY-1NCT03631199
Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab in Previously Untreated Locally Advanced or Metastatic Non-squamous and Squamous NSCLC Subjects
A Phase 3 study testing canakinumab, pembrolizumab and carboplatin in people with Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 152 sites in 41 countries.
Trial summary
This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- canakinumab, pembrolizumab and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 673 participants
- Where
- 152 sitesin 41 countries
- Study dates
- 21 Dec 2018to 26 Jan 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced stage IIIB or stage IV NSCLC for treatment in the first-line setting
- Known PD-L1 status determined by a Novartis designated central laboratory. A newly obtained tissue biopsy or an archival biopsy (block or slides) is required for PD-L1 determination (PD-L1 IHC 22C3 pharmDx assay), prior to study randomization. Note: For the safety run-in part, known PD-L1 status is not required.
- Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.
- At least 1 measurable lesion by RECIST 1.1
Who cannot join
- Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways).
- Prior treatment with canakinumab or drugs of a similar mechanism of action (IL-1β inhibitor).
- Subjects with epidermal growth factor receptor (EGFR) sensitizing mutations (identified in exons 19, 20, or 21), and/or ALK rearrangement by locally approved laboratory testing.
- Previously untreated or symptomatic central nervous system (CNS) metastases or lepto-meningeal disease.
- Subject with suspected or proven immune-compromised state or infections.
- Subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.
Trial locations and contacts
152 sites in 41 countries.
152 sites in 41 countries
Spain13 sites
Novartis Investigative Site
Badalona, Barcelona, 08916
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Barcelona, 08036
Novartis Investigative Site
Donostia / San Sebastian, Gipuzkoa, 20014
Novartis Investigative Site
Granada, Andalusia, 18014
Novartis Investigative Site
Las Palmas de Gran C, Las Palmas, 35016
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Málaga, 29010
Novartis Investigative Site
Valencia, 46026
Novartis Investigative Site
Zaragoza, 50009
Germany12 sites
Novartis Investigative Site
Berlin, 13125
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 51109
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Georgsmarienhütte, 49124
Novartis Investigative Site
Gerlingen, 70839
Novartis Investigative Site
Göttingen, Lower Saxony, 37075
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Leipzig, Saxony, 04347
Novartis Investigative Site
Munich, Bavaria, 81377
Italy11 sites
Novartis Investigative Site
Avellino, AV, 83100
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20133
Novartis Investigative Site
Milan, 20141
Novartis Investigative Site
Modena, MO, 41124
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site
Padova, PD, 35128
Novartis Investigative Site
Parma, PR, 43126
Novartis Investigative Site
Perugia, PG, 06129
Novartis Investigative Site
Rozzano, MI, 20089
Japan9 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
Novartis Investigative Site
Himeji, Hyōgo, 670-8520
Novartis Investigative Site
Nagoya, Aichi-ken, 4648681
Novartis Investigative Site
Osaka, 5458586
Novartis Investigative Site
Sakai, Osaka, 591-8555
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Sunto Gun, Shizuoka, 4118777
Novartis Investigative Site
Ube, Yamaguchi, 755-0241
Novartis Investigative Site
Yokohama, Kanagawa, 241-8515
China8 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Changchun, Jilin, 130012
Novartis Investigative Site
Changsha, Hunan, 410013
Novartis Investigative Site
Hangzhou, Zhejiang, 310022
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Harbin, Heilongjiang, 150081
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Wuhan, Hubei, 430030
Novartis Investigative Site
Xi’an, Shanxi, 710038
India6 sites
Novartis Investigative Site
Gurgaon, Haryana, 122 001
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500034
Novartis Investigative Site
Hyderabad, Telangana, 500082
Novartis Investigative Site
Jaipur, Rajasthan, 302017
Novartis Investigative Site
Kolkata, West Bengal, 700160
Novartis Investigative Site
Pune, Maharashtra, 411013
France5 sites
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Marseille, Bouches Du Rhone, 13915
Novartis Investigative Site
Montpellier, 34070
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Paris, 75231
Russia5 sites
Novartis Investigative Site
Arkhangelsk, 163045
Novartis Investigative Site
Omsk, 644013
Novartis Investigative Site
Saint Petersburg, 192148
Novartis Investigative Site
Saint Petersburg, 196603
Novartis Investigative Site
Saint Petersburg, 197022
South Korea5 sites
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06591
Taiwan5 sites
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Tainan, 704
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 333
Thailand5 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Khon Kaen, THA, 40002
Novartis Investigative Site
Songkhla, Hat Yai, 90110
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Pacific Shores Medical Group
Long Beach, California, 90813
USC Kenneth Norris Comprehensive Cancer Center
Los Angeles, California, 90033
AdventHealth
Orlando, Florida, 32804
Australia4 sites
Novartis Investigative Site
Melbourne, Victoria, 3000
Novartis Investigative Site
Murdoch, Western Australia, 6150
Novartis Investigative Site
Westmead, New South Wales, 2145
Novartis Investigative Site
Wooloongabba, Queensland, 4102
Czechia4 sites
Novartis Investigative Site
Brno, 625 00
Novartis Investigative Site
Brno, 656 53
Novartis Investigative Site
Ostrava, Vitkovice, 703 84
Novartis Investigative Site
Prague, 128 08
Malaysia4 sites
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuantan, Pahang, 25100
Novartis Investigative Site
Kuching, Sarawak, 93586
Philippines4 sites
Novartis Investigative Site
City of Taguig, National Capital Region, 1634
Novartis Investigative Site
Makati City, 1229
Novartis Investigative Site
Quezon, 1102
Novartis Investigative Site
San Juan City, 1502
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, Bilkent Cankaya, 06800
Novartis Investigative Site
Ankara, Sihhiye-Altindag, 06230
Novartis Investigative Site
Edirne, Merkez, 22030
Novartis Investigative Site
Istanbul, Bagcilar, 34214
United Kingdom4 sites
Novartis Investigative Site
High Heaton, Newcastle Upon Tyne, NE7 7DN
Novartis Investigative Site
London, NW3 2QG
Novartis Investigative Site
Manchester, M20 2BX
Novartis Investigative Site
Plymouth, PL6 8DH
Brazil3 sites
Novartis Investigative Site
Barretos, São Paulo, 14784 400
Novartis Investigative Site
São Paulo, São Paulo, 01246 000
Novartis Investigative Site
São Paulo, São Paulo, 04014-002
Canada3 sites
Novartis Investigative Site
Brampton, Ontario, L6R 3J7
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Poland3 sites
Novartis Investigative Site
Gliwice, 44 101
Novartis Investigative Site
Poznan, 60 569
Novartis Investigative Site
Tomaszw Mazowiecki, 97-200
Singapore3 sites
Novartis Investigative Site
Singapore, 119228
Novartis Investigative Site
Singapore, 168583
Novartis Investigative Site
Singapore, S308433
Argentina2 sites
Novartis Investigative Site
Caba, Buenos Aires, C1426ANZ
Novartis Investigative Site
Caba, C1431FWO
Austria2 sites
Novartis Investigative Site
Linz, Upper Austria, 4020
Novartis Investigative Site
Salzburg, 5020
Chile2 sites
Novartis Investigative Site
Santiago, 8420383
Novartis Investigative Site
Temuco, Araucania, 4810469
Greece2 sites
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 185 47
Lebanon2 sites
Novartis Investigative Site
Beirut, 1100 2070
Novartis Investigative Site
Saida, 652
Netherlands2 sites
Novartis Investigative Site
Groningen, 9713 GZ
Novartis Investigative Site
Groningen, 9728 NZ
Portugal2 sites
Novartis Investigative Site
Lisbon, 1769 001
Novartis Investigative Site
Porto, 4200-072
Romania2 sites
Novartis Investigative Site
Cluj-Napoca, Cluj, 400015
Novartis Investigative Site
Craiova, Dolj, 200347
Slovakia2 sites
Novartis Investigative Site
Bratislava, 83310
Novartis Investigative Site
Kosice-Saca, 958 01
Colombia1 site
Novartis Investigative Site
Valledupar, Cesar Department, 200001
About this study
Official title: 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)
This was a Phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC participants.
Read the detailed description
The study primarily assessed the safety and tolerability (safety run-in Part A) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab, and then, the efficacy (double-blind, randomized, placebo-controlled Part B) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- canakinumab, canakinumab-matching placebo, pembrolizumab, carboplatin, cisplatin
- Keywords
- ACZ885, canakinumab, pembrolizumab, carboplatin, cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, NSCLC, non-small cell lung cancer, non small cell lung cancer, squamous, non-squamous, hsCRP, IL-1β, PD-L1, CANOPY, CANOPY-1, platinum-based doublet chemotherapy, first line therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
canakinumabDrug
Also called ACZ885
canakinumab 200 mg subcutaneous (s.c.) injection every 3 weeks (squamous and non-squamous)
canakinumab-matching placeboDrug
canakinumab placebo every 3 weeks (squamous and non-squamous)
pembrolizumabDrug
200 mg every 3 weeks (squamous and non-squamous)
carboplatinDrug
Area Under the Curve (AUC) 5 mg/mL*min every 3 weeks (non-squamous) or AUC 6 mg/mL*min (squamous)
cisplatinDrug
75 mg/m^2 every 3 weeks (non-squamous)
paclitaxelDrug
200 mg/m^2 every 3 weeks (squamous)
nab-paclitaxelDrug
100 mg/m^2 on Days 1, 8, and 15 of every cycle (squamous)
pemetrexedDrug
500 mg/m^2 every 3 weeks (non-squamous)
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort A | Experimental | Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and pemetrexed. Receives: Drug: canakinumab; Drug: pembrolizumab; Drug: carboplatin; Drug: pemetrexed |
| Part 1: Cohort B | Experimental | Safety run-in, canakinumab in combination with pembrolizumab, cisplatin, and pemetrexed. Receives: Drug: canakinumab; Drug: pembrolizumab; Drug: cisplatin; Drug: pemetrexed |
| Part 1: Cohort C | Experimental | Safety run-in, canakinumab in combination with pembrolizumab, carboplatin, and paclitaxel. Receives: Drug: canakinumab; Drug: pembrolizumab; Drug: carboplatin; Drug: paclitaxel |
| Part 2: Canakinumab+pembro+CTx | Experimental | Double-blind, randomized, placebo-controlled, canakinumab in combination with pembrolizumab and platinum-based doublet chemotherapy. Receives: Drug: canakinumab; Drug: pembrolizumab; Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: nab-paclitaxel; Drug: pemetrexed |
| Part 2: Placebo+pembro+CTx | Other | Double-blind, randomized, placebo-controlled, canakinumab-matching placebo in combination with pembrolizumab and platinum-based doublet chemotherapy. Receives: Drug: canakinumab-matching placebo; Drug: pembrolizumab; Drug: carboplatin; Drug: cisplatin; Drug: paclitaxel; Drug: nab-paclitaxel; Drug: pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.
Measured: During the first 42 days of dosing
Part 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
Progression free survival was defined as the time from randomization to the date of the first documented radiological progression using RECIST 1.1 (Response evaluation criteria in solid tumor) or death due to any cause.
Measured: 18 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Overall survival is defined as the time from date of randomization to date of death due to any cause.
Measured: Up to approximately 32 months
Secondary outcomes (28)
Part 1 (Safety Run-in): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Overall Response Rate (ORR) Per Investigator Assessment Using RECIST v1.1
ORR was defined as the percentage of participants with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Up to approximately 26 months
Part 1 (Safety run-in): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Measured: Up to approximately 14 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Disease Control Rate (DCR) Per Investigator Assessment Using RECIST v1.1
Disease control rate was defined as the percentage of participants with complete response (CR) or partial response (PR) or participants with stable disease (SD) as per investigator assessment according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD=Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
Measured: Up to approximately 26 months
Part 1 (Safety run-in): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Duration of Response (DOR) Per Investigator Assessment Using RECIST v1.1
Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. DOR only applied to participants whose best overall response was CR or PR based on tumor response data per local review. If a participant did not have an event, DOR was censored at the date of last adequate tumor assessment. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Up to approximately 26 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Response (TTR) Per Investigator Assessment Using RECIST v1.1
Time to response (TTR) was defined as duration of time between the date of randomization and the date of first documented response of either CR or PR, according to RECIST 1.1 criteria. Duration of response was defined as the time from first documented response of CR or PR to date of first documented progression or death due to any cause, according to RECIST 1.1 criteria. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Measured: Up to approximately 26 months
Part 1 (Safety Run-in): Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Measured: Predose (0 hours (h)) on Day 1 of Cycles 1, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26, 78 and 130 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Number of Participants With Antidrug Antibodies (ADA) of Canakinumab
Participants with at least one ADA-positive sample.
Measured: Up to approximately 26 months
Part 1 (Safety run-in): Antidrug Antibodies (ADAs) of Pembrolizumab
Participants with at least one ADA-positive sample.
Measured: Predose (0 h) on Day 1 of Cycles 1, 2, 4, 8, 12, 16 (Cycle length =21 days), at end of treatment & then at 26 days after last dose
Part 2 (Double-blind, Randomized, Placebo-controlled): Antidrug Antibodies (ADA) of Pembrolizumab
Participants with at least one ADA-positive sample.
Measured: Up to approximately 26 months
Part 1 (Safety Run-in): Serum Canakinumab Concentration
Measured: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Canakinumab Concentration
Measured: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, Post dose on Cycle 5 day 8, at end of treatment & then at 26, 78 and 130 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Serum Pembrolizumab Concentration
Measured: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Serum Pembrolizumab Concentration
Measured: Predose (0 h) on Day 1 of Cycles 1-6, 8, 12, 16, Postdose on day 2, 8, 15 of Cycle 1, at end of treatment & then at 26 days after last dose (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Pemetrexed Concentration
Measured: Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Pemetrexed Concentration
Measured: Predose (0 h) and end of infusion on Cycle 1 and 2; 1, 4, 8 h post infusion on Cycle 1; 1, 2, 4, 8h post infusion on Cycle 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Cisplatin Concentration
Measured: Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Cisplatin Concentration
Measured: Predose (0 h) and end of infusion on Cycle 1 and 2; 2, 4, 8 h post infusion on Cycle 1; 1.5, 2, 4, 8 h post infusion on Cycle 2 (Cycle length = 21 days)
Part 1 (Safety Run-in): Plasma Carboplatin Concentration
Measured: Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Carboplatin Concentration
Measured: Predose (0 h), end of infusion, 1, 2, 4, 8 h post infusion on Cycles 1 and 2 (Cycle length =21 days)
Part 1 (Safety Run-in): Plasma Paclitaxel Concentration
Measured: Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Paclitaxel Concentration
Measured: Predose (0 h) and end of infusion on Cycle 1 and 2; 4, 8, 12 h post infusion on Cycle 1; 4, 6, 8, 12 h post infusion on Cycle 2 (Cycle length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Plasma Nab-paclitaxel Concentration
Measured: Predose (0 h) and end of infusion on Cy 1 and 2, 4, 8, 12 h post infusion on Cy 1, 4, 6, 8, 12 h post infusion on Cy 2 (Cy length =21 days)
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive 10-point Deterioration (TTDD) Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, dyspnea, and chest pain). Scores for each scale and single-item range from 0 to 100, with higher scores indicating higher level of symptoms. TTDD for chest pain, cough and dyspnea was defined as the time from randomization to the date of event, which was defined as at least 10 points absolute worsening from baseline of the corresponding scale score, with no later change below this threshold ie.<10 points was observed, or if this worsening was observed at the last assessment for the subject, or death due to any cause (whichever occurred earlier). If a subject did not have an event, TTDD was censored at the last adequate assessment.
Measured: Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Time to Definitive Deterioration in Global Health Status/Quality of Life, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) is a questionnaire developed to assess the health-related quality of life of cancer participants. It assesses 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores range from 0 to 100. A high score for the functional or global health status scales indicates a high level of functioning or QoL; a high score for a symptom scale indicates a high level of symptoms.
Measured: Up to approximately 25 months
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire
The EQ-5D-5L questionnaire is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L measures 5 items on mobility, self-care, usual activities, pain/discomfort, anxiety/depression, measured on 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A utility index can be computed from the EQ 5D-5L descriptive system with utility scores ranging from -0.281 (worst imaginable health state) to 1 (best imaginable health state), with -0.281 representing an "unconscious" health state. A single index value is analyzed for the EQ-5D-5L score. An increase from baseline in the EQ-ED-5L utility index is indicative of an improvement.). CFB = change from baseline
Measured: Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Part 2 (Double-blind, Randomized, Placebo-controlled): Change From Baseline in Score as Per the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire - Visual Analog Scale (VAS)
The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status. CFB = change from baseline
Measured: Assessed every 3 weeks from Week 3 through Week 108, at follow-up visits 1, 2, 3, 4, and 5 (follow-up visits occurred every 26 days from week 108), and at 7 and 28 days post-disease progression, all up to a maximum of 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start21 Dec 2018
- Primary completion9 Aug 2021
- Study completion26 Jan 2026
Why it stopped: Results of primary analysis showed addition of canakinumab to combination treatment did not improve tumor response or overall survival; the decision to stop the trial was not due to safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 673 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631199
- Sponsor's protocol ID
- CACZ885U2301
- Other IDs
- 2024-511490-29-00
- Acronym
- CANOPY-1
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2018
- Last updated
- 17 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Publications
Tan DSW, Felip E, de Castro G, Solomon BJ, Greystoke A, Cho BC, Cobo M, Kim TM, Ganguly S, Carcereny E, Paz-Ares L, Bennouna J, Garassino MC, Schenker M, Kim SW, Brase JC, Bury-Maynard D, Passos VQ, Deudon S, Dharan B, Song Y, Caparica R, Johnson BE. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial. J Clin Oncol. 2024 Jan 10;42(2):192-204. doi: 10.1200/JCO.23.00980. Epub 2023 Dec 1.
PubMed 38039427