Extensive-stage Small-cell Lung CancerPhase 2NCT06306560
A Study of Adebrelimab Combined With Famitinib and Chemotherapy in the Treatment of ES-SCLC.
A Phase 2 study testing adebrelimab, famitinib and chemotherapy in people with Extensive-stage Small-cell Lung Cancer, run by Harbin Medical University.
Trial summary
This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer
- What is being tested?
- adebrelimab, famitinib and chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2024to 15 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years old, male or female
- Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging)
- Never received prior systemic therapy for extensive stage small cell lung cancer
- Have a measurable tumour target lesion (meeting RECIST 1.1 criteria)
- Expected survival > 3 months
- ECOG PS: 0-1 points
Show all 9Show fewer
- Normal function of major organs
- Women of childbearing potential must undergo a negative pregnancy test (βHCG) prior to initiation of treatment, and women of childbearing potential and men (who are sexually active with women of childbearing potential) must agree to use effective contraception uninterruptedly for the duration of the treatment period and for 6 months after the administration of the last therapeutic dose
- Patients voluntarily enrolled in this study by signing an informed consent form
Who cannot join
- Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer
- Active tuberculosis infection, or a history of previous tuberculosis infection
- Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction
- Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
- Subjects with the presence of any severe and/or uncontrolled disease
Show all 13Show fewer
- Imaging showing tumour invasion of large vessels or poor demarcation from large vessels
- Susceptibility to bleeding, risk of hemoptysis, and history of significant coagulation disorders
- History of psychotropic substance abuse, alcoholism or drug addiction
- Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA test value exceeding the upper limit of normal value Hepatitis C reference HCV antibody positive with HCV viral titre test value exceeding the upper limit of normal value)
- Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive
- Patients who are unable to comply with the trial protocol or who are unable to cooperate with follow-up visits
- Patients who, in the opinion of the investigator, should not be enrolled in the trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer
This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.
Read the detailed description
This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Being tested
- adebrelimab, famitinib, chemotherapy
- Keywords
- Adebrelimab, Famitinib, Small-cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adebrelimabDrug
Also called SHR-1316
adebrelimab IV
famitinibDrug
Also called SHR1020
famitinib PO
chemotherapyDrug
Also called cisplatin/carboplatin and etoposide
chemotherapy IV
| Study group | Role | What they receive |
|---|---|---|
| Immuno-cherapy for extensive small cell lung cancer | Experimental | Adebrelimab in combination with famitinib and chemotherapy Receives: Drug: adebrelimab; Drug: famitinib; Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival
Proportion of disease progression or death from randomization to 6 months of treatment.
Measured: up to 6 months
Secondary outcomes (7)
12-month progression-free survival
Proportion of disease progression or death from randomization to 12 months of treatment.
Measured: up to 12 months
Objective Response Rate
Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: up to 24 months
Disease control rate
Disease Control Rate, determined using RECIST v1.1 criteria.
Measured: up to 24 months
Overall Survival
Defined as the time from randomization to death from any cause.
Measured: up to 24 months
AEs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: up to 24 months
QoL
Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales
Measured: up to 24 months
Progression-Free-Survival
Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbin Zhao, Harbin Medical University
- Investigators
- Yanbin Zhao, MD, Principal investigator, Harbin Medical University Cancer Hosptital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306560
- Sponsor's protocol ID
- MA-SCLC-II-018
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Adebrelimab in Combination With Famitinib and Chemotherapy for the Treatment of First-line Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06306560
- Acronym / sponsor ID
- MA-SCLC-II-018
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Keywords
- Adebrelimab, Famitinib, Small-cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 12 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.
This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.
Detailed description
This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immuno-cherapy for extensive small cell lung cancer | Experimental | Drug: adebrelimab, Drug: famitinib, Drug: chemotherapyAdebrelimab in combination with famitinib and chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-80 years old, male or female
- Patients with pathologically confirmed extensive stage small cell lung cancer (according to the Veterans Administration Lung Study Group, VALG staging)
- Never received prior systemic therapy for extensive stage small cell lung cancer
- Have a measurable tumour target lesion (meeting RECIST 1.1 criteria)
- Expected survival > 3 months
Key exclusion criteria (13 listed)
- Previous or concurrent other malignant tumours within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial or non-invasive bladder cancer
- Active tuberculosis infection, or a history of previous tuberculosis infection
- Uncontrolled, symptomatic brain metastases that are not effectively controlled or a history of psychiatric illness that cannot be easily controlled or severe intellectual or cognitive dysfunction
- Subjects with active, known or suspected autoimmune disease, hypothyroidism requiring only hormone replacement therapy, skin disorders not requiring systemic therapy (e.g., vitiligo, psoriasis, or alopecia areata) may be eligible for enrolment
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage
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 |
|---|---|---|
| adebrelimabAlso: SHR-1316adebrelimab IV | Drug | Immuno-cherapy for extensive small cell lung cancer |
| famitinibAlso: SHR1020famitinib PO | Drug | Immuno-cherapy for extensive small cell lung cancer |
| chemotherapyAlso: cisplatin/carboplatin and etoposidechemotherapy IV | Drug | Immuno-cherapy for extensive small cell lung cancer |
Primary outcome
6-month progression-free survival
Time frame: up to 6 months
Proportion of disease progression or death from randomization to 6 months of treatment.
7 secondary outcomes
12-month progression-free survival
Time frame: up to 12 months
Objective Response Rate
Time frame: up to 24 months
Disease control rate
Time frame: up to 24 months
Overall Survival
Time frame: up to 24 months
AEs
Time frame: up to 24 months
QoL
Time frame: up to 24 months
Progression-Free-Survival
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
Yanbin Zhao, MD principal investigator
Harbin Medical University Cancer Hosptital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adebrelimab, famitinib and chemotherapy in people with Extensive-stage Small-cell Lung Cancer, run by Harbin Medical University.
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 9 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: opening soon, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanbin Zhao, MD (13904811741, zhaoyanbin1978@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival (time frame: up to 6 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 12 Mar 2024.