Metastatic Non-squamous Non Small Cell Lung CancerPhase 3CONTERNONCT04786964
Study of Pemetrexed+Platinum Chemotherapy With or Without Cosibelimab in First Line Metastatic Non-squamous NSCLC
A Phase 3 study testing Cosibelimab, Cisplatin and Carboplatin in people with Metastatic Non-squamous Non Small Cell Lung Cancer, run by Checkpoint Therapeutics, Inc. at 22 sites in 8 countries.
Trial summary
This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-squamous Non Small Cell Lung Cancer
- What is being tested?
- Cosibelimab, Cisplatin and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 8 Dec 2021to 30 Dec 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
- Has measurable disease.
- Has not received prior systemic treatment for their advanced/metastatic NSCLC.
- Can provide tumor tissue.
- Has a life expectancy of at least 3 months.
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- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Has adequate organ function
- If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
- If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 180 days after the last dose of study medication and chemotherapeutic agents.
Who cannot join
- Has predominantly squamous cell histology NSCLC.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study medication.
- Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose).
- Received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication.
- Completed palliative radiotherapy within 7 days of the first dose of study medication.
- Is expected to require any other form of antineoplastic therapy while on study.
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- Received a live-virus vaccination within 30 days of planned start of study medication.
- Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis.
- Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb).
- Known sensitivity to any component of cisplatin, carboplatin or pemetrexed.
- Has active autoimmune disease that has required systemic treatment in past 2 years.
- Is on chronic systemic steroids.
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- Is unable or unwilling to take folic acid or vitamin B12 supplementation.
- Had prior treatment with any other anti-programmed cell death-1 (PD-1), or PD-ligand 1 (PD-L1) or PD-L2 agent or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- Has an active infection requiring therapy.
- Has known history of Human Immunodeficiency Virus (HIV).
- Has known active Hepatitis B or C.
- Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.
- Is a known regular user of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
- Has symptomatic ascites or pleural effusion.
- Has active or history of interstitial lung disease or a history of (non infectious) pneumonitis that required steroids or current pneumonitis.
- Has had an allogeneic tissue/solid organ transplant.
- Any known uncontrolled or significant cardiovascular disease.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
Russia15 sites
Research Site
Arkhangelsk
Research Site
Chelyabinsk
Research Site
Kaliningrad
Research Site
Kazan'
Research Site
Kursk
Research Site
Kuzmolovskiy
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Sochi
Research Site
Tomsk
Research Site
Volgograd
About this study
Official title: A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer
This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).
The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.
Read the detailed description
CK-301-301 is a Phase 3, open-label, multicenter, randomized, active-controlled study of the safety and efficacy of IV administered cosibelimab 1200 mg Q3W in combination with platinum/pemetrexed chemotherapy versus chemotherapy alone in subjects with NSCLC who have not previously received systemic therapy for advanced disease and in whom epidermal growth factor receptor-directed therapy or anaplastic lymphoma kinase-directed therapy was not indicated. Subjects were randomized 2:1 to receive cosibelimab 1200 mg in combination with pemetrexed and platinum therapy, or pemetrexed and platinum therapy alone. Subjects were stratified by smoking status (never versus former/current), cisplatin vs carboplatin, and PD-L1 status (Tumor Proportion Score [TPS] < 1% vs 1-49% vs ≥ 50%) prior to randomization. Subjects with unevaluable PD-L1 status were included with the TPS < 1% group.
- Being tested
- Cosibelimab, Cisplatin, Carboplatin, Pemetrexed, Folic acid 350-1000 μg
- Keywords
- Metastatic, non-small cell lung cancer, nonsquamous, PD-L1, PD-1, PDL1, PD1, Lung neoplasms, Cosibelimab, Non-squamous NSCLC, Carcinoma, non-small cell lung, Antineoplastic agents, CK-301, Anti-PD-L1
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosibelimabDrug
IV infusion
CisplatinDrug
IV infusion
CarboplatinDrug
IV infusion
PemetrexedDrug
IV infusion
Folic acid 350-1000 μgDietary supplement
Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
Vitamin B12 1000 μgDietary supplement
Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
Dexamethasone 4mgDrug
For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
| Study group | Role | What they receive |
|---|---|---|
| Cosibelimab | Experimental | Participants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. Receives: Drug: Cosibelimab; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Dietary Supplement: Folic acid 350-1000 μg; Dietary Supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4mg |
| Control | Active comparator | Participants receive pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m^2 IV Q3W until progression. Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Dietary Supplement: Folic acid 350-1000 μg; Dietary Supplement: Vitamin B12 1000 μg; Drug: Dexamethasone 4mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Defined as the time from randomization to death due to any cause.
Measured: Approximately 3 years.
Secondary outcomes (4)
Progression-Free Survival (PFS)
Defined as the time from randomization until disease progression by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: Approximately 3 years.
Objective Response Rate (ORR)
Defined as the proportion of participants who have a confirmed complete response or partial response per RECIST v1.1
Measured: Approximately 3 years.
Duration of Response (DOR)
Defined as the time from the earliest date of documented response until earliest date of disease progression (per RECIST v1.1) or death from any cause, whichever comes first.
Measured: Approximately 3 years.
Number of Participants Who Experienced an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug.
Measured: Approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start8 Dec 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Why it stopped: Regional political conflict
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.
- Other trials for Metastatic Non-squamous Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Checkpoint Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786964
- Sponsor's protocol ID
- CK-301-301
- Acronym
- CONTERNO
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2021
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 3 Study of Cosibelimab (CK-301) in Combination With Platinum+Pemetrexed Chemotherapy in Subjects With First-Line Metastatic Non-squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04786964
- Acronym / sponsor ID
- CONTERNO / CK-301-301
- Keywords
- Metastatic, non-small cell lung cancer, nonsquamous, PD-L1, PD-1, PDL1, PD1, Lung neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Regional political conflict
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Checkpoint Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an efficacy and safety study of cosibelimab (CK-301) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned in a 2:1 ratio to receive cosibelimab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin).
The primary hypothesis is that cosibelimab in combination with pemetrexed/platinum chemotherapy prolongs Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.
Detailed description
CK-301-301 is a Phase 3, open-label, multicenter, randomized, active-controlled study of the safety and efficacy of IV administered cosibelimab 1200 mg Q3W in combination with platinum/pemetrexed chemotherapy versus chemotherapy alone in subjects with NSCLC who have not previously received systemic therapy for advanced disease and in whom epidermal growth factor receptor-directed therapy or anaplastic lymphoma kinase-directed therapy was not indicated. Subjects were randomized 2:1 to receive cosibelimab 1200 mg in combination with pemetrexed and platinum therapy, or pemetrexed and platinum therapy alone. Subjects were stratified by smoking status (never versus former/current), cisplatin vs carboplatin, and PD-L1 status (Tumor Proportion Score [TPS] < 1% vs 1-49% vs ≥ 50%) prior to randomization. Subjects with unevaluable PD-L1 status were included with the TPS < 1% group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cosibelimab | Experimental | Drug: Cosibelimab, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Dietary Supplement: Folic acid 350-1000 μg, Dietary Supplement: Vitamin B12 1000 μg, Drug: Dexamethasone 4mgParticipants receive cosibelimab 1200 mg intravenously (IV) PLUS pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by cosibelimab 1200 mg IV PLUS pemetrexed 500 mg/m^2 IV Q3W until progression. |
| Control | Active comparator | Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Dietary Supplement: Folic acid 350-1000 μg, Dietary Supplement: Vitamin B12 1000 μg, Drug: Dexamethasone 4mgParticipants receive pemetrexed 500 mg/m^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pemetrexed 500 mg/m^2 IV Q3W until progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
- Has measurable disease.
- Has not received prior systemic treatment for their advanced/metastatic NSCLC.
- Can provide tumor tissue.
Key exclusion criteria (27 listed)
- Has predominantly squamous cell histology NSCLC.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of study medication.
- Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g., erlotinib, crizotinib, cetuximab), c) Had major surgery (<3 weeks prior to first dose).
- Received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication.
- Completed palliative radiotherapy within 7 days of the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CosibelimabIV infusion | Drug | Cosibelimab |
| CisplatinIV infusion | Drug | Control, Cosibelimab |
| CarboplatinIV infusion | Drug | Control, Cosibelimab |
| PemetrexedIV infusion | Drug | Control, Cosibelimab |
| Folic acid 350-1000 μgOrally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed. | Dietary supplement | Control, Cosibelimab |
| Vitamin B12 1000 μgIntramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration. | Dietary supplement | Control, Cosibelimab |
| Dexamethasone 4mgFor prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration. | Drug | Control, Cosibelimab |
Primary outcome
Overall Survival (OS)
Time frame: Approximately 3 years.
Defined as the time from randomization to death due to any cause.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Approximately 3 years.
Objective Response Rate (ORR)
Time frame: Approximately 3 years.
Duration of Response (DOR)
Time frame: Approximately 3 years.
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Approximately 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cosibelimab, Cisplatin and Carboplatin in people with Metastatic Non-squamous Non Small Cell Lung Cancer, run by Checkpoint Therapeutics, Inc. at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia, Brazil, Georgia, Malaysia, New Zealand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Approximately 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.