Non-squamous Non-small Cell Lung CancerPhase 2/3NCT06335355
A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients
A Phase 2/3 study testing Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin, Camrelizumab + Pemetrexed + Carboplatin and Adebrelimab + Pemetrexed + Carboplatin in people with Non-squamous Non-small Cell Lung Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-squamous Non-small Cell Lung Cancer
- What is being tested?
- Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin, Camrelizumab + Pemetrexed + Carboplatin and Adebrelimab + Pemetrexed + Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- Mar 2024to Oct 2030
- Phase
- Phase 2/3
- 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
- The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.
- At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.
- Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.
- At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .
- The participant is expected to have a life expectancy of at least 12 weeks.
- Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed.
- The participant must have adequate bone marrow and organ function.
Who cannot join
- Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.
- Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.
- Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
- Subjects with inadequately controlled pain related to their tumor(s).
- Subjects with a history of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ following mastectomy (allowing for hormonal treatment for non-metastatic prostate or breast cancer), and papillary thyroid cancer which have achieved complete remission for at least 5 years prior to screening and do not require or are not expected to require further treatment during the study period.
- Subjects who have received Chinese herbal anti-tumor treatment within 2 weeks prior to initiating the study treatment.
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- Subjects whose toxicities and/or complications from previous interventions have not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) Grade ≤1.
- Subjects participating in another clinical study or whose initiation of study treatment is less than 4 weeks since the end of the last clinical study (last dose administration), or less than five half-lives of that study drug, whichever is shorter.
- Subjects who have received systemic immunostimulant treatment within 4 weeks prior to starting the study treatment.
- Subjects who have received systemic immunosuppressive treatment within 2 weeks prior to starting the study treatment.
- Subjects with any active, known, or suspected autoimmune disease.
- Subjects with severe heart disease.
- Subjects who have experienced arterial or venous thrombotic events within 3 months prior to starting the study treatment.
- Subjects with active syphilis infection.
- Subjects who have had a severe infection within 4 weeks prior to starting the study treatment.
- Subjects who have previously undergone or are planning to undergo allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Subjects with a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- Subjects with a history of substance abuse of psychoactive drugs, alcoholism, or drug addiction.
- Subjects whom the investigator believes have any medical condition (such as pulmonary, metabolic, endocrine, or neurological diseases, congenital disorders, etc.), psychiatric conditions, or social circumstances that could potentially interfere with the subject's rights, safety, health, or ability to provide informed consent, cooperate, and participate in the study, or interfere with the assessment of the investigational drug, interpretation of subject safety data, or study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Tumor Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Jinming Yu
About this study
Official title: A Phase II/III, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11/KEAP1/KRAS Mutations
Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Being tested
- Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin, Camrelizumab + Pemetrexed + Carboplatin, Adebrelimab + Pemetrexed + Carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adebrelimab + SHR-8068 + Pemetrexed + CarboplatinDrug
Adebrelimab,1200mg; SHR-8068, 1.0 mg/kg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min
Camrelizumab + Pemetrexed + CarboplatinDrug
Camrelizumab,200mg;Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min
Adebrelimab + Pemetrexed + CarboplatinDrug
Adebrelimab,1200mg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin |
| Treatment group B | Active comparator | Not described Receives: Drug: Camrelizumab + Pemetrexed + Carboplatin |
| Treatment group C | Active comparator | Not described Receives: Drug: Adebrelimab + Pemetrexed + Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed Objective Response Rate (Phase One)
Measured: about 3 years
Overall Survival (Phase Two)
Measured: about 3.5 years
Secondary outcomes (6)
The incidence and severity of Adverse Events (AEs) (Phases One and Two)
Measured: about 4.5 years
Duration of Response (DoR) based on Investigator Assessment (Phases One and Two)
Measured: about 6.5 years
Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two)
Measured: about 6.5 years
Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two)
Measured: about 6.5 years
Overall Survival (OS) (Phase One)
Measured: about 3.5 years
Objective Response Rate (ORR) based on Investigator Assessment (Phase Two)
Measured: about 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 401 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335355
- Sponsor's protocol ID
- SHR-1316-307
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11/KEAP1/KRAS Mutations
- ClinicalTrials.gov ID
- NCT06335355
- Acronym / sponsor ID
- SHR-1316-307
- Conditions
- Non-squamous Non-small Cell Lung Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 401 participants (estimated)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2024 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 28 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.
Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin |
| Treatment group B | Active comparator | Drug: Camrelizumab + Pemetrexed + Carboplatin |
| Treatment group C | Active comparator | Drug: Adebrelimab + Pemetrexed + Carboplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant voluntarily joins this clinical research study, understands the research procedures, and is capable of providing written informed consent by signing the Informed Consent Form.
- At the time of signing the Informed Consent Form, participants must be between the ages of 18 and 75 years old (inclusive), with no gender restrictions.
- Diagnosed with advanced or metastatic non-squamous NSCLC (non-small cell lung cancer) confirmed by histology or cytology.
- At least one measurable tumor lesion outside the central nervous system that meets the RECIST v1.1guidelines .
- The participant is expected to have a life expectancy of at least 12 weeks.
Key exclusion criteria (20 listed)
- Pathologically or cytologically confirmed mixed Small Cell Lung Cancer (SCLC), sarcomatoid carcinoma, or neuroendocrine carcinoma.
- Subjects with untreated or active Central Nervous System (CNS) metastases, those with a history of leptomeningeal metastasis, or those currently presenting with leptomeningeal metastasis.
- Subjects with spinal cord compression that has not been radically treated by surgery and/or radiotherapy.
- Subjects with inadequately controlled pain related to their tumor(s).
- Subjects with a history of or concurrent other malignancies, except for basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, in situ cervical cancer, localized prostate cancer, ductal carcinoma in situ following mastectomy (allowing for hormonal treatment for non-metastatic prostate or breast cancer), and papillary thyroid cancer which have achieved complete remission for at least 5 years prior to screening and do not require or are not expected to require further treatment during the study period.
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 |
|---|---|---|
| Adebrelimab + SHR-8068 + Pemetrexed + CarboplatinAdebrelimab,1200mg; SHR-8068, 1.0 mg/kg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min | Drug | Treatment group A |
| Camrelizumab + Pemetrexed + CarboplatinCamrelizumab,200mg;Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min | Drug | Treatment group B |
| Adebrelimab + Pemetrexed + CarboplatinAdebrelimab,1200mg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min | Drug | Treatment group C |
Primary outcome
Investigator-assessed Objective Response Rate (Phase One)
Time frame: about 3 years
Overall Survival (Phase Two)
Time frame: about 3.5 years
6 secondary outcomes
The incidence and severity of Adverse Events (AEs) (Phases One and Two)
Time frame: about 4.5 years
Duration of Response (DoR) based on Investigator Assessment (Phases One and Two)
Time frame: about 6.5 years
Disease Control Rate (DCR) based on Investigator Assessment (Phases One and Two)
Time frame: about 6.5 years
Progression-Free Survival (PFS) based on Investigator Assessment (Phases One and Two)
Time frame: about 6.5 years
Overall Survival (OS) (Phase One)
Time frame: about 3.5 years
Objective Response Rate (ORR) based on Investigator Assessment (Phase Two)
Time frame: about 4.5 years
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 28 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin, Camrelizumab + Pemetrexed + Carboplatin and Adebrelimab + Pemetrexed + Carboplatin in people with Non-squamous Non-small Cell Lung Cancer, run by Shanghai Shengdi Pharmaceutical Co., Ltd 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 7 inclusion and 20 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 28 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 combined 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.
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 Junli Qang (+0518-81220121, Junli.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed Objective Response Rate (Phase One) (time frame: about 3 years). 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 28 Mar 2024.