Extensive Small Cell Lung CancerPhase 2NCT06406673
A Phase II Clinical Study of Cadonilimab in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
A Phase 2 study testing Cadonilimab+EC/ET+RT and Cadonilimab+vorolanib in people with Extensive Small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Small cell lung cancer (SCLC) accounts for 15% of lung cancer cases and is an aggressive cancer characterized by rapid growth, early metastasis, and a poor prognosis. Approximately 75% of SCLC patients present with extensive-stage disease at the time of diagnosis, which is classically defined as a disease that cannot… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Small Cell Lung Cancer
- What is being tested?
- Cadonilimab+EC/ET+RT and Cadonilimab+vorolanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects voluntarily participated in the study and signed informed consent;
- Male or female aged ≥18 years ;
- Expected survival time ≥3 months;
- ECOG 0-1;
- Patients with extensive-stage small-cell Lung cancer confirmed by histopathology and/or cytology (according to Veterans Administration Lung Study Group (VALG) staging); 5-1）Cohort_1 patients who have not received any previous systemic anti-tumor therapy for extensive-stage small cell lung cancer, and included all patients with ≤5 extrapulmonary metastases.
- 5-2）Cohort2 patients with previous failure or intolerance to standard therapy for extensive-stage small cell lung cancer and received at most one systemic treatment:
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- Those who have previously failed first-line platinum-based chemotherapy combined with immune checkpoint inhibitors, and have received at most one systemic treatment, as follows:
- Receiving less than 2 lines of systemic therapy in the advanced stage of the disease;
- ②Immune checkpoint inhibitors include atezolizumab, durvalumab, slulimumab, adebelimab, etc.;
- ③Disease progression confirmed by imaging during or after the latest treatment b) Those who have only received first-line platinum-containing drug treatment in the past and failed, and have not received immune checkpoint inhibitor treatment, as follows:
- Receiving less than 2 lines of systemic therapy in the advanced stage of the disease; ② The first-line treatment must be platinum-containing chemotherapy; ③ Disease progression confirmed by imaging during or after the latest treatment
- Consent to provide archival tumor tissue specimens (10 unstained sections (anti-slip) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If participants cannot provide tumor tissue samples, they can be enrolled if they meet other inclusion and exclusion criteria, after the evaluation of the investigator;
- Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions that had been previously treated with radiation could be included in a measurable lesion only if there was definite disease progression after radiation therapy.
- Organ function level must meet the following criteria： 8-1) Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L; 8-2) Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).
- 8-3) Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both ≤5.0 ULN when liver metastasis was present; 8-4) coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN; 8-5) no severe cardiac dysfunction with left ventricular ejection fraction ≥50%; 8-6) proteinuria ≤2+ or ≤1000mg/24h; 8-7) Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities such as ALP elevation, hyperuricemia, and hyperglycemia, as judged by the investigator, and toxicity without safety risk, such as alopecia, grade 2 peripheral neurotoxicity, or decreased hemoglobin ≥90g/L, as judged by the investigator); 8-8) For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment.
- Women of reproductive age should agree to use effective contraception during the study period and for six months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men should agree to use contraception during the study period and for six months after the study period ends;
- Patients will be able to communicate well with the investigator, understand and comply with the requirements of the study.
Who cannot join
- Histologically or cytologically confirmed NSCLC;
- Previous medications:For Cohort_1: Exclude those who have received systemic anti-tumor therapy or with >5 extrapulmonary metastases; For Cohort_2: Those who have received more than one systemic treatment regimen
- Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
- Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis or cavities, and the researcher determines that entering the study will cause a risk of bleeding(Only for Cohort_2).
- Received any surgery or invasive treatment or operation within 4 weeks before enrollment (excluding intravenous catheterization, puncture drainage, puncture biopsy, etc.)
- The patient currently has central nervous system (CNS) metastases or active brain or meningeal metastases. Treated subjects with BMS were required to meet the following criteria: asymptomatic; No radiographically demonstrated progression ≥4 weeks after completion of treatment; Completion of treatment ≥14 days before the first dose of the study drug; Systemic corticosteroid therapy (> 10mg/ day prednisone or equivalent) is not required for ≤14 days prior to the first dose of the study drug
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- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality, or laboratory abnormality that, in the investigator's judgment, reasonably suspects the patient to have a medical condition or condition that is not suitable for the use of the study drug (such as having seizures that require treatment), or that would affect the interpretation of the study results, or put the patient at high risk;
- Have received or plan to receive live attenuated vaccine within 4 weeks prior to initial administration;
- Currently receiving anti-HBV treatment;
- Received approved or under development systematic anti-tumor therapy within 28 days before enrollment;
- Those who are known to be allergic to the active ingredient or excipients of the drug in this study;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Qiming Wang, doctor, 13783590691, qimingwang1006@126.com
About this study
Official title: A Phase II Clinical Study of Cadonilimab(PD-1/CTLA-4 Bi-Specific Antibody) in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for 15% of lung cancer cases and is an aggressive cancer characterized by rapid growth, early metastasis, and a poor prognosis. Approximately 75% of SCLC patients present with extensive-stage disease at the time of diagnosis, which is classically defined as a disease that cannot be encompassed by a single radiation field. Before the era of immunotherapy, the standard first-line therapy for ES-SCLC was platinum-based chemotherapy with etoposide; Once complete remission (CR) or partial remission (PR) was achieved after chemotherapy, consolidative thoracic radiation was recommended. Despite this standard treatment, the median overall survival (OS) of ES-SCLC is about 8-11 months, which has not changed for about 40 years. Combining concurrent radiotherapy of the thorax and immunochemotherapy may have a synergistic effect.
Besides, for patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. With the most recent approval of EP plus a programmed death ligand 1(PD-L1) inhibitor, there are now more therapeutic options for managing ES-SCLC.The best second-line therapy after combination of chemo-immunotherapy is not well defined, as many second-line therapies were studied only after use of EP. However, second-line treatment options for patients with relapsed ES-SCLC are limited and include reintroduction of EP (with or without an immunotherapy), lurbinectedin, and topotecan.
Read more
Therefore, we designed this trial to explore the efficacy and safety of cadonilimab as second-line therapy for ES-SCLC. We present a safety profile and a final analysis of ORR.
In this single-center phase 2 trial, Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP for two cycles (induction phase), then, those who did not progress received concurrent palliative RT and two cycles of cadonilimab with EC/EP (combination phase). Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment (maintenance phase). Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib, until disease progression or unacceptable toxicity.
The primary endpoints was objective response rate (ORR); the second endpoints were progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and treatment-emergent adverse event (TEAE) .
- Conditions
- Extensive Small Cell Lung Cancer
- Being tested
- Cadonilimab+EC/ET+RT, Cadonilimab+vorolanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab+EC/ET+RTDrug
Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP for two cycles (induction phase), then, those who did not progress received concurrent palliative RT and two cycles of cadonilimab with EC/EP (combination phase). Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment (maintenance phase).
Cadonilimab+vorolanibDrug
Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib, until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cohort_1 | Experimental | Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP and received concurrent palliative RT. Receives: Drug: Cadonilimab+EC/ET+RT |
| Cohort_2 | Experimental | Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib. Receives: Drug: Cadonilimab+vorolanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
Measured: 24 months
Secondary outcomes (4)
Progression-free survival (PFS)
The PFS is defined as the time from the first dose of medication to disease progression or death, whichever occurred first.
Measured: 24 months
Disease control rate (DCR)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).
Measured: 24 months
Overall survival (OS)
The OS is defined as the time from study entry to death from any cause.
Measured: 24 months
Treatment-Emergent Adverse Event (TEAE)
TEAE is defined as any adverse and unexpected change in body structure, function, or chemistry or any exacerbation of an existing condition (i.e., any clinically significant adverse change in frequency and/or intensity) during treatment. The type, frequency, and severity of TEAE will be assessed during treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start16 Oct 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406673
- Sponsor's protocol ID
- AK104-SCLC-01
- Status last verified
- Sep 2023
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Cadonilimab(PD-1/CTLA-4 Bi-Specific Antibody) in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06406673
- Acronym / sponsor ID
- AK104-SCLC-01
- Conditions
- Extensive Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 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.
Small cell lung cancer (SCLC) accounts for 15% of lung cancer cases and is an aggressive cancer characterized by rapid growth, early metastasis, and a poor prognosis. Approximately 75% of SCLC patients present with extensive-stage disease at the time of diagnosis, which is classically defined as a disease that cannot be encompassed by a single radiation field. Before the era of immunotherapy, the standard first-line therapy for ES-SCLC was platinum-based chemotherapy with etoposide; Once complete remission (CR) or partial remission (PR) was achieved after chemotherapy, consolidative thoracic radiation was recommended. Despite this standard treatment, the median overall survival (OS) of ES-SCLC is about 8-11 months, which has not changed for about 40 years. Combining concurrent radiotherapy of the thorax and immunochemotherapy may have a synergistic effect.
Besides, for patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. With the most recent approval of EP plus a programmed death ligand 1(PD-L1) inhibitor, there are now more therapeutic options for managing ES-SCLC.The best second-line therapy after combination of chemo-immunotherapy is not well defined, as many second-line therapies were studied only after use of EP. However, second-line treatment options for patients with relapsed ES-SCLC are limited and include reintroduction of EP (with or without an immunotherapy), lurbinectedin, and topotecan.
Therefore, we designed this trial to explore the efficacy and safety of cadonilimab as second-line therapy for ES-SCLC. We present a safety profile and a final analysis of ORR.
In this single-center phase 2 trial, Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP for two cycles (induction phase), then, those who did not progress received concurrent palliative RT and two cycles of cadonilimab with EC/EP (combination phase). Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment (maintenance phase). Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib, until disease progression or unacceptable toxicity.
The primary endpoints was objective response rate (ORR); the second endpoints were progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and treatment-emergent adverse event (TEAE) .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort_1 | Experimental | Drug: Cadonilimab+EC/ET+RTCohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP and received concurrent palliative RT. |
| Cohort_2 | Experimental | Drug: Cadonilimab+vorolanibCohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All subjects voluntarily participated in the study and signed informed consent;
- Male or female aged ≥18 years ;
- Expected survival time ≥3 months;
- ECOG 0-1;
- Patients with extensive-stage small-cell Lung cancer confirmed by histopathology and/or cytology (according to Veterans Administration Lung Study Group (VALG) staging); 5-1）Cohort_1 patients who have not received any previous systemic anti-tumor therapy for extensive-stage small cell lung cancer, and included all patients with ≤5 extrapulmonary metastases.
Key exclusion criteria (13 listed)
- Histologically or cytologically confirmed NSCLC;
- Previous medications:For Cohort_1: Exclude those who have received systemic anti-tumor therapy or with >5 extrapulmonary metastases; For Cohort_2: Those who have received more than one systemic treatment regimen
- Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
- Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis or cavities, and the researcher determines that entering the study will cause a risk of bleeding(Only for Cohort_2).
- Received any surgery or invasive treatment or operation within 4 weeks before enrollment (excluding intravenous catheterization, puncture drainage, puncture biopsy, etc.)
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 |
|---|---|---|
| Cadonilimab+EC/ET+RTCohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with EC/EP for two cycles (induction phase), then, those who did not progress received concurrent palliative RT and two cycles of cadonilimab with EC/EP (combination phase). Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment (maintenance phase). | Drug | Cohort_1 |
| Cadonilimab+vorolanibCohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib, until disease progression or unacceptable toxicity. | Drug | Cohort_2 |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Treatment-Emergent Adverse Event (TEAE)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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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.
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+EC/ET+RT and Cadonilimab+vorolanib in people with Extensive Small Cell Lung Cancer, run by Henan Cancer Hospital 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 17 inclusion and 13 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 9 May 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 24 months). 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 9 May 2024.