Lung CancerPhase 4NCT06276933
A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
A Phase 4 study testing Camrelizumab + chemotherapy+Thalidomide in people with Lung Cancer and Camrelizumab, run by Tongji University.
Trial summary
To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Camrelizumab
- What is being tested?
- Camrelizumab + chemotherapy+Thalidomide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2024to 22 Nov 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, both male and female.
- Histopathology or cytology confirmed advanced Stage IIIB-IV non-small cell lung cancer.
- No prior systemic treatment to advanced NSCLC . Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 12 months from randomization since the last chemotherapy cycle.
- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
- Have a life expectancy of at least 3 months.
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- All baseline laboratory requirements will be assessed.
- Can swallow pills normally.
- Remission of all acute toxic reactions to previous antitumor therapy to grade 0-1 or to the level specified in the exclusion criteria.
- Female Subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose, are not breastfeeding, and must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. Male subjects whose partners are fertile women should be surgically sterilized or agree to use effective contraception during the trial period and 90 days after the last administration of the study drug, and sperm donation is not allowed during the study period.
- Subjects has voluntarily agreed to participate by giving written informed consent. Willing and able to follow planned visits, research treatments, laboratory tests and other test procedures.
Who cannot join
- Patients with non-small cell lung cancer diagnosed with other histopathological types, including patients with NSCLC containing small cell lung cancer components.
- Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
- Patients who have previously received PD-(L)1 or CTLA-4 treatment.
- Subjects with active CNS metastases are excluded.
- Subjects with active, known or suspected autoimmune disease. Participants who are in a stable state and do not require systemic immunosuppressive therapy are permitted to enroll.
- Congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection.
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- Have the following poorly controlled infectious diseases: active viral hepatitis B or C; Have active TB or are currently receiving anti-TB treatment.
- There is past or present objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (such as bronchitis, vasculitis obliterans), drug-induced pneumonia, active pneumonia on CT examination, or severe impairment of lung function.
- Subjects with clinically significant cardiovascular and cerebrovascular diseases.
- Active infection (CTCAE\> Grade 2).
- Diagnosed with immune deficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor treatment within 7 days prior to study enrollment; Physiological doses of glucocorticoids are permitted.
- Other malignancies developed within 5 years prior to admission, excluding adequately treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
- Subjects received major surgery within 4 weeks of the first dose of study treatment or planned during the study period.
- Subjects had administration of a live, attenuated vaccine within 4 weeks of the first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study.
- Subjects who are alcohol dependent or have a history of drug or substance abuse within the last 1 year.
- Subjects with a known neurological or mental disorder, such as epilepsy, dementia, or the presence of a peripheral nervous system disorder.
- Subjects had or plan to have allogeneic bone marrow transplantation or solid organ transplant.
- Pregnant or lactating female; The fertile subject is unwilling or unable to take effective contraceptive measures.
- Known allergy to the investigational drug or excipient.
- Received any other investigational medicine treatment or participated in another interventional clinical study within 4 weeks prior to signing the ICF.
- Abnormal coagulation function .Thrombosis or thromboembolic event within 6 months prior to the start of study treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject\'s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
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: A Prospective, Multicenter, Double-blind, Randomized Controlled Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced NSCLC
To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients
- Conditions
- Lung Cancer, Camrelizumab
- Being tested
- Camrelizumab + chemotherapy+Thalidomide, Camrelizumab + chemotherapy+placebo
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab + chemotherapy+ThalidomideDrug
Camrelizumab + chemotherapy+Thalidomide Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210
Drug: Thalidomide Thalidomide 100mg，po qd； Other Name: Thalidomide
Drug: Chemotherapy
Platinum-based chemotherapy:
Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles.
Other Name: Platinum-based chemotherapy
Camrelizumab + chemotherapy+placeboDrug
Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210
Drug: placebo 100mg placebo 100mg，po qd；
Drug: Chemotherapy
Platinum-based chemotherapy:
Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles.
Other Name: Platinum-based chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Chemotherapy+Thalidomide | Experimental | Not described Receives: Drug: Camrelizumab + chemotherapy+Thalidomide |
| Camrelizumab + chemotherapy+placebo | Active comparator | Not described Receives: Drug: Camrelizumab + chemotherapy+placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Measured: 2 years
Secondary outcomes (7)
Median time to RCCEP
Median time to RCCEP
Measured: 2 years
Median time to RCCEP of level 3 or above
Median time to RCCEP of level 3 or above
Measured: 2 years
Incidence rate of ≥G3 grade RCCEP
Incidence rate of ≥G3 grade RCCEP
Measured: 2 years
Overall Response Rate (ORR)
Overall Response Rate (ORR)
Measured: 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: 2 years
Overall Survival(OS)
Overall Survival(OS)
Measured: 2 years
Treatment-related Adverse Events (TRAE)
Treatment-related Adverse Events (TRAE)
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 Feb 2024
- Study start22 Feb 2024 (estimated)
- Primary completion22 Nov 2025 (estimated)
- Study completion22 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Principal investigator, Caicun Zhou, Dongfang Hospital Affiliated to Tongji University
- Investigators
- Anwen Xiong, MD, Study director, Department of Oncology, Shanghai pulmonary hospital Shanghai, China, 200433
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276933
- Sponsor's protocol ID
- MA-NSCLC-II-039
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Double-blind, Randomized Controlled Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT06276933
- Acronym / sponsor ID
- MA-NSCLC-II-039
- Conditions
- Lung Cancer, Camrelizumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 22 Feb 2024 (estimated)
- Primary completion
- 22 Nov 2025 (estimated)
- Study completion
- 22 Nov 2026 (estimated)
- First posted
- 26 Feb 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 explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Chemotherapy+Thalidomide | Experimental | Drug: Camrelizumab + chemotherapy+Thalidomide |
| Camrelizumab + chemotherapy+placebo | Active comparator | Drug: Camrelizumab + chemotherapy+placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old, both male and female.
- Histopathology or cytology confirmed advanced Stage IIIB-IV non-small cell lung cancer.
- No prior systemic treatment to advanced NSCLC . Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 12 months from randomization since the last chemotherapy cycle.
- Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Key exclusion criteria (22 listed)
- Patients with non-small cell lung cancer diagnosed with other histopathological types, including patients with NSCLC containing small cell lung cancer components.
- Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
- Patients who have previously received PD-(L)1 or CTLA-4 treatment.
- Subjects with active CNS metastases are excluded.
- Subjects with active, known or suspected autoimmune disease. Participants who are in a stable state and do not require systemic immunosuppressive therapy are permitted to enroll.
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 |
|---|---|---|
| Camrelizumab + chemotherapy+ThalidomideCamrelizumab + chemotherapy+Thalidomide Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210 Drug: Thalidomide Thalidomide 100mg，po qd； Other Name: Thalidomide Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy | Drug | Camrelizumab+Chemotherapy+Thalidomide |
| Camrelizumab + chemotherapy+placeboDrug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210 Drug: placebo 100mg placebo 100mg，po qd； Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy | Drug | Camrelizumab + chemotherapy+placebo |
Primary outcome
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Time frame: 2 years
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
7 secondary outcomes
Median time to RCCEP
Time frame: 2 years
Median time to RCCEP of level 3 or above
Time frame: 2 years
Incidence rate of ≥G3 grade RCCEP
Time frame: 2 years
Overall Response Rate (ORR)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival(OS)
Time frame: 2 years
Treatment-related Adverse Events (TRAE)
Time frame: 2 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 26 Feb 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.
Anwen Xiong, MD study director
Department of Oncology, Shanghai pulmonary hospital Shanghai, China, 200433
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Camrelizumab + chemotherapy+Thalidomide in people with Lung Cancer and Camrelizumab, run by Tongji 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 11 inclusion and 22 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 26 Feb 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Anwen Xiong, MD (18221013620, anwenxiong@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) (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 Feb 2024.