Non-small Cell Lung CancerPhase 2NCT06331650
A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer
A Phase 2 study testing cadonilimab in people with Non-small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- cadonilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2023to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures.
- Age ≥18 years old and ≤75 years old when signing ICF.
- histologically or cytologically confirmed advanced or postoperative recurrent non-small cell lung cancer (AJCC 8th edition).
- STK11 mutations were detected by NGS, and no other sensitive mutations could be targeted therapy (including EGFR, ALK, ROS1, RET, c-Met, HER2, BRAF gene rearrangement, fusion, amplification, and skipping).
- The patient had not received systemic antitumor therapy.
- Patients who had received one prior chemotherapy regimen were allowed, regardless of whether chemotherapy was administered before, after, or concurrently with targeted therapy.
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- Patients receiving adjuvant or neoadjuvant therapy were allowed if adjuvant/neoadjuvant therapy had been completed at least 12 months before diagnosis of advanced or postoperative recurrent NSCLC.
- The interval between the end of previous nonsystemic antitumor therapy and the start of study medication had to be 4 weeks or more. Treatment-related AE recovered to CTCAE 4.03≤ grade 1 (except grade 2 alopecia).
- have at least one measurable target lesion as assessed by the investigator according to iRECIST requirements within 4 weeks before enrollment.
- If available, patients can provide eligible tumor tissue for PD-L1 expression level measurement.
- an ECOG PS score of 0 or 1 within 7 days before the first dose of study medication.
- predicted survival time ≥12 weeks (3 months).
- had good major organ function, defined as meeting the following criteria, and had not received blood transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days before the first dose of study medication.
- Female patients must meet one of the following conditions:
- 1) menopause, defined as absence of menses for at least 1 year and no confirmed cause other than menopause, or (2) having undergone sterilization (removal of ovaries and/or uterus) 3) be fertile, provided that: Patients had to have a negative serum pregnancy test within 7 days before randomization and agree to use contraception with an annual failure rate of <1% or to abstain from heterosexual intercourse for at least 120 days from the date of written informed consent until the last dose of trial drug was administered. At least 150 days after the last dose of chemotherapy) (contraceptive methods with an annual failure rate of <1% include bilateral tubal ligation, male sterilization, proper use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices, and copper intrauterine devices or condoms), and Do not breastfeed.
- 15.Male patients had to agree to either abstain from sex (avoid heterosexual intercourse) or to use contraception, as specified by either abstinence or use of condoms to prevent exposure of the drug to the embryo during chemotherapy (paclitaxel/pemetrexed/carboplatin) for the duration of treatment with a woman of reproductive age or a pregnant partner and for at least 150 days after the last dose of chemotherapy. Regular abstinence (e.g., calendar day, ovulation, basal body temperature, or postovulatory methods of contraception) and in vitro ejaculation are ineligible methods of contraception.
Who cannot join
- received systemic therapy for advanced NSCLC within 4 weeks after enrollment;
- the subjects had a history or concurrent history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- candidates for or prior recipients of organ or bone marrow transplantation.
- uncontrollable pleural, pericardial, or ascites with appropriate interventions.
- subjects with clinically symptomatic CNS metastases (e.g., brain edema, need for hormonal intervention, or progression of brain metastases). Patients who had received previous treatment for brain or meningeal metastases were eligible if they had been clinically stable (on MRI) for at least 2 months and had stopped systemic hormone therapy (at a dose of >10mg per day of prednisone or other iso-efficacy hormones) for more than 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangdong, Guangzhou, 510000
zhou chegnzhi, doctor, 13560351186, doctorzcz@163.com
About this study
To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- cadonilimab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cadonilimabDrug
Cardunnilizumab: the recommended dose is 10mg/kg every 3 weeks on the first day of each cycle; Discontinuation of the drug may be considered if intolerable adverse reactions occur.
| Study group | Role | What they receive |
|---|---|---|
| cadonilimab | Experimental | Not described Receives: Drug: cadonilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments and ORR
Objective response rate (ORR) as assessed by investigators according to iRECIST in patients with STK11-mutated advanced or postoperative recurrent non-small cell lung cancer treated with carbognilumab plus chemotherapy as first-line treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start9 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- zhou chengzhi, doctor, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331650
- Sponsor's protocol ID
- CROC202314
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06331650
- Acronym / sponsor ID
- CROC202314
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cadonilimab | Experimental | Drug: cadonilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures.
- Age ≥18 years old and ≤75 years old when signing ICF.
- histologically or cytologically confirmed advanced or postoperative recurrent non-small cell lung cancer (AJCC 8th edition).
- STK11 mutations were detected by NGS, and no other sensitive mutations could be targeted therapy (including EGFR, ALK, ROS1, RET, c-Met, HER2, BRAF gene rearrangement, fusion, amplification, and skipping).
- The patient had not received systemic antitumor therapy.
Key exclusion criteria (5 listed)
- received systemic therapy for advanced NSCLC within 4 weeks after enrollment;
- the subjects had a history or concurrent history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix).
- candidates for or prior recipients of organ or bone marrow transplantation.
- uncontrollable pleural, pericardial, or ascites with appropriate interventions.
- subjects with clinically symptomatic CNS metastases (e.g., brain edema, need for hormonal intervention, or progression of brain metastases). Patients who had received previous treatment for brain or meningeal metastases were eligible if they had been clinically stable (on MRI) for at least 2 months and had stopped systemic hormone therapy (at a dose of >10mg per day of prednisone or other iso-efficacy hormones) for more than 2 weeks.
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 |
|---|---|---|
| cadonilimabCardunnilizumab: the recommended dose is 10mg/kg every 3 weeks on the first day of each cycle; Discontinuation of the drug may be considered if intolerable adverse reactions occur. | Drug | cadonilimab |
Primary outcome
Safety assessments and ORR
Time frame: 2 years
Objective response rate (ORR) as assessed by investigators according to iRECIST in patients with STK11-mutated advanced or postoperative recurrent non-small cell lung cancer treated with carbognilumab plus chemotherapy as first-line treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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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.
zhou chengzhi, doctor principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cadonilimab in people with Non-small Cell Lung Cancer, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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 16 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhou chengzhi, doctor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessments and ORR (time frame: 2 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 26 Mar 2024.