Extensive Stage Lung Small Cell CarcinomaPhase 3RALLYNCT06672133
Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC
A Phase 3 study testing Adebrelimab and Radiation Therapy in people with Extensive Stage Lung Small Cell Carcinoma, run by Jinming Yu.
Trial summary
This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Stage Lung Small Cell Carcinoma
- What is being tested?
- Adebrelimab and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2029
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, male or female;
- Histologically or cytologically confirmed extensive stage small cell lung cancer (according to the Veterans Lung Administration Lung Study Group, VALG stage);
- ECOG performance status score 0 ~ 1;
- No prior line of systemic therapy for ES-SCLC;
- Liver metastases ≤ 3 at diagnosis;
- Patients without previous brain metastases or treated asymptomatic CNS metastases,
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- Expected survival ≥ 12 weeks;
- At least one measurable target lesion (according to RECISTv1.1 criteria) on imaging assessment (CT or MRI) within 4 weeks prior to enrollment;
- The function of vital organs meets the requirements;
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must agree to use effective contraception during the trial and 2 months after the last dose of adalimumab or 6 months after the chemotherapy agent, whichever is longer;
- Patients voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up.
Who cannot join
- Histologically or cytologically determined as a mixed pathological type with components such as non-small cell lung cancer;
- Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and previous imaging assessments;
- Spinal cord compression that is not relieved by surgery and/or radiotherapy;
- Clinically symptomatic third space effusion requiring repeated drainage within 2 weeks, such as pericardial effusion, pleural effusion, and abdominal effusion that are still uncontrollable by pumping or other treatments;
- Complicated with other malignant tumors ≤ 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed);
- Patients with active, known, or suspected autoimmune disease. Patients with type 1 diabetes treated with stable doses of insulin, hypothyroidism requiring hormone replacement therapy only, and skin diseases (e.g., eczema, vitiligo, or psoriasis) not requiring systemic therapy and not exacerbated within the year before the screening period were excluded;
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- Patients diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor therapy within 7 days before the first dose of study drug; physiological doses of glucocorticoids (prednisone ≤ 10 mg/day or equivalent) are allowed;
- HBsAg positive and HBV DNA copy number greater than the upper limit of normal (1000 copies/ml or 500 IU/ml), or HCV positive (HCV RNA or HCV Ab detection suggests acute and chronic infection); known HIV positive history or known acquired immunodeficiency syndrome (AIDS);
- A history of idiopathic pulmonary fibrosis, interstitial pneumonia, tissue pneumonia (such as occlusive vasculitis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or clinically symptomatic active pneumonia; or other severe lung disease that seriously affects lung function;
- Patients with active pulmonary tuberculosis (TB) or history of active pulmonary tuberculosis infection ≤ 48 weeks before screening, regardless of treatment;
- Presence of severe infection at randomization, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.;
- Major surgery within 28 days prior to randomization, or planned major surgery during the study period;
- Use of live attenuated vaccines within 28 days prior to randomization, or anticipated need for live attenuated vaccines during the study;
- Cardiac function and disease which is considered clinically significant by the investigator;
- Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
- Known hypersensitivity to the study drug or excipients, known serious allergic reactions to any monoclonal antibody; history of allergy to carboplatin/cisplatin or etoposide;
- Received any other investigational drug or participated in another interventional clinical study within 4 weeks before signing the ICF;
- Known mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse;
- Pregnant or lactating women; as judged by the investigator, the patient has other factors that may cause forced halfway termination of this study, such as non-compliance with the protocol, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, accompanied by family or social factors, which may affect the safety of patients, or the collection of data and samples.
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: Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC: a Randomized Controlled Phase III Clinical Study
This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
I.To compare investigator-assessed progression free survival (PFS) between adebrelimab plus radiotherapy and adebrelimab alone.
II.To compare overall survival (OS) between adebrelimab plus radiotherapy and adebrelimab alone.
SECONDARY OBJECTIVES:
I.To assess the ORR (objective response rate)、DoR (Duration of response) 、DCR(Disease control rate) toxicity between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
II.To assess six months and one-year PFS rate、one-year and two-year OS rate between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
III.To assess the safety and tolerability.
EXPLORATORY OBJECTIVE:
I.To detect biomarkers associated with efficacy OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive adebrelimab IV over 30 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.
ARM II: Patients receive adebrelimab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo computed tomography (CT)、magnetic resonance imaging (MRI) or positron emission tomography and computed tomography (PET/CT) scan, throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
- Being tested
- Adebrelimab, Radiation Therapy
- Keywords
- adebrelimab, radiotherapy, ES-SCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
Also called SHR-1316
Given：IV
Radiation TherapyRadiation
Also called RT, Radiotherapy, Consolidation radiotherapy, Irradiation
Undergo radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm Combined Radiotherapy | Experimental | After randomization，patients receive adebrelimab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only.
Patients undergo CT, MRI or PET/CT scan,throughout the trial. Patients also undergo blood and tissue collection throughout the trial. Receives: Drug: Adebrelimab; Radiation: Radiation Therapy |
| Arm Non-radiotherapy | Active comparator | After randomization，patients receive adebrelimab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo CT, MRI or PET/CT scan,throughout the trial. Patients also undergo blood and tissue collection throughout the trial. Receives: Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: Up to approximately 36 months
OS
Measured: Up to approximately 36 months
Secondary outcomes (6)
ORR
Measured: Up to approximately 36 months
DoR
Measured: Up to approximately 36 months
DCR
Measured: Up to approximately 36 months
6m and 1-year PFS rate
Measured: 6 Months and 12 Months
1- and 2-year OS rates
Measured: 1 year and 2 years
Adverse events
Safety, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE 5.0 criteria
Measured: Up to approximately 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Lung Small Cell CarcinomaStudies 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
- Model description
- Subjects who had SD/PR/CR assessed after induction immunotherapy were randomized 1:1 with PFS and OS set as co-primary endpoints for this study. The HR of mOS in the maintenance phase was conservatively estimated to be meaningful in the adalimumab combined with thoracic radiotherapy group compared with the adalimumab group, with a significance level α of 0.05 (2-sided), and no less than 80% OS events would be observed (1-β difference between the 375 groups). A total of 471 subjects are required to be enrolled. Considering a dropout rate of 10%, 524 subjects were required. In summary, a total of at least 524 subjects were required to be enrolled in this study.
- Masking
- None (open label)
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinming Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinming Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672133
- Sponsor's protocol ID
- MA-SCLC-III-023
- Acronym
- RALLY
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2024
- Last updated
- 5 Nov 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC: a Randomized Controlled Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT06672133
- Acronym / sponsor ID
- RALLY / MA-SCLC-III-023
- Keywords
- adebrelimab, radiotherapy, ES-SCLC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Jinming YuUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Nov 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 phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
I.To compare investigator-assessed progression free survival (PFS) between adebrelimab plus radiotherapy and adebrelimab alone.
II.To compare overall survival (OS) between adebrelimab plus radiotherapy and adebrelimab alone.
SECONDARY OBJECTIVES:
I.To assess the ORR (objective response rate)、DoR (Duration of response) 、DCR(Disease control rate) toxicity between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
II.To assess six months and one-year PFS rate、one-year and two-year OS rate between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
III.To assess the safety and tolerability.
EXPLORATORY OBJECTIVE:
I.To detect biomarkers associated with efficacy OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive adebrelimab IV over 30 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.
ARM II: Patients receive adebrelimab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo computed tomography (CT)、magnetic resonance imaging (MRI) or positron emission tomography and computed tomography (PET/CT) scan, throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects who had SD/PR/CR assessed after induction immunotherapy were randomized 1:1 with PFS and OS set as co-primary endpoints for this study. The HR of mOS in the maintenance phase was conservatively estimated to be meaningful in the adalimumab combined with thoracic radiotherapy group compared with the adalimumab group, with a significance level α of 0.05 (2-sided), and no less than 80% OS events would be observed (1-β difference between the 375 groups). A total of 471 subjects are required to be enrolled. Considering a dropout rate of 10%, 524 subjects were required. In summary, a total of at least 524 subjects were required to be enrolled in this study.
| Arm | Type | Receives |
|---|---|---|
| Arm Combined Radiotherapy | Experimental | Drug: Adebrelimab, Radiation: Radiation TherapyAfter randomization，patients receive adebrelimab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo CT, MRI or PET/CT scan,throughout the trial. Patients also undergo blood and tissue collection throughout the trial. |
| Arm Non-radiotherapy | Active comparator | Drug: AdebrelimabAfter randomization，patients receive adebrelimab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT, MRI or PET/CT scan,throughout the trial. Patients also undergo blood and tissue collection throughout the trial. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years, male or female;
- Histologically or cytologically confirmed extensive stage small cell lung cancer (according to the Veterans Lung Administration Lung Study Group, VALG stage);
- ECOG performance status score 0 ~ 1;
- No prior line of systemic therapy for ES-SCLC;
- Liver metastases ≤ 3 at diagnosis;
Key exclusion criteria (19 listed)
- Histologically or cytologically determined as a mixed pathological type with components such as non-small cell lung cancer;
- Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and previous imaging assessments;
- Spinal cord compression that is not relieved by surgery and/or radiotherapy;
- Clinically symptomatic third space effusion requiring repeated drainage within 2 weeks, such as pericardial effusion, pleural effusion, and abdominal effusion that are still uncontrollable by pumping or other treatments;
- Complicated with other malignant tumors ≤ 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed);
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-1316Given：IV | Drug | Arm Combined Radiotherapy, Arm Non-radiotherapy |
| Radiation TherapyAlso: RT, Radiotherapy, Consolidation radiotherapy, IrradiationUndergo radiation therapy | Radiation | Arm Combined Radiotherapy |
Primary outcome
PFS
Time frame: Up to approximately 36 months
OS
Time frame: Up to approximately 36 months
6 secondary outcomes
ORR
Time frame: Up to approximately 36 months
DoR
Time frame: Up to approximately 36 months
DCR
Time frame: Up to approximately 36 months
6m and 1-year PFS rate
Time frame: 6 Months and 12 Months
1- and 2-year OS rates
Time frame: 1 year and 2 years
Adverse events
Time frame: Up to approximately 36 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 5 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adebrelimab and Radiation Therapy in people with Extensive Stage Lung Small Cell Carcinoma, run by Jinming Yu.
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 11 inclusion and 19 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 5 Nov 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 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?
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 Llinlin Wang, PhD (+86-15665785800, wanglinlinatjn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to approximately 36 months). The study lists 2 primary outcomes in all. 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 5 Nov 2024.