Limited Stage Small Cell Lung CancerPhase 2/3SURPASSNCT05623267
Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT
A Phase 2/3 study testing Sugemalimab in people with Limited Stage Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Stage Small Cell Lung Cancer
- What is being tested?
- Sugemalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1、18 years or older. 2、Histologically or cytologically confirmed small cell lung cancer. 3、ECOG PS=0-1 at enrollment; 4、Limited-stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses).
- 5、Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses surgery.
- 6、Completion of 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy.
- 7、After the completion of concurrent or sequential chemoradiotherapy, prophylactic intracranial irradiation (PCI) is allowed based on the common practice of individual sites.
- 8、The start of concurrent radiotherapy should be no later than the last day of the second course of chemotherapy (the first day of the third cycle of chemotherapy). The interval between the end of chemotherapy cycle and beginning of radiotherapy must not exceed 35 days for sequential chemoradiotherapy.
- 9、Radiotherapy must be either total 60-66Gy over 6 weeks for the standard qd regimen or total 45Gy over 3 weeks for hyperfractionated bid schedules.
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- 10、Absence of progression after concurrent/sequential chemoradiotherapy (responses should be complete response [CR], partial response [PR] and stable disease [SD]); 11、For patients not receiving PCI, the first dose of sugemalimab shall be administered within 42 days after the completion of chemoradiation therapy. For patients receiving PCI, the first dose of sugemalimab shall be administered within 56 days after the completion of chemoradiation therapy.
- 12、Life expectancy ≥ 12 weeks. 13、Can provide tumor tissue samples (fresh or archived) for whole exome sequencing; 14、Women of childbearing potential and fertile men must agree to use an effective contraceptive method from signing the master ICF until 180 days after the last dose of investigational product. Women of childbearing potential include premenopausal women and women who became menopausal less than 2 years ago. Women of childbearing potential must have a negative pregnancy test ≤7 days prior to the first dose of investigational product.
- 15、The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent.
Who cannot join
- Histologically or cytologically diagnosed mixed small cell lung cancer or non-small cell lung cancer.
- Extensive-stage small cell lung cancer.
- Has malignant pleural or pericardial effusion.
- Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors.
- Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.
- Has history of interstitial lung disease (ILD), drug-induced ILD, or active ILD which required systemic glucocorticoid or immunosuppressive therapy.
Show all 11Show fewer
- History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
- Pregnant or lactating women.
- Those who are allergic to the research drug or its components.
- Subjects who are deemed unable to comply with the study requirements or complete the study.
- Those with insufficient function of bone marrow or other important organs.
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, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, MD, zhangli@sysucc.org.cn
About this study
Official title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy
The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.
Read the detailed description
This study is planned to enroll approximately 346 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to the experimental and control arm. The experimental arm would receive sugemalimab, while the control arm would receive placebo.Tumor assessment will be conducted using computed tomography/magnetic resonance imaging and MRD detection will be performed along with radiologic review during each visit. The above assessment will be conducted every 12 weeks for the first 2 years, every 24 weeks for the third year, and annually thereafter until confirmed disease progression per RECIST 1.1 or death.The primary endpoint is PFS ,which is defined as the time from the date of randomization to the date of disease progression (per RECIST 1.1), any cause of death, loss to follow-up, or initiation of new antitumor therapy, whichever occurred first.
- Conditions
- Limited Stage Small Cell Lung Cancer
- Being tested
- Sugemalimab, Placebo
- Keywords
- Limited-stage Small-cell Lung Cancer（LS-SCLC）, Minimal Residual Disease（MRD）, Immunotherapy
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugemalimabDrug
Recombinant anti-PD-L1 fully human monoclonal antibody
PlaceboDrug
Placebo of Sugemalimab
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Intravenous infusion (IV) of Sugemalimab 1200 mg at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity. Receives: Drug: Sugemalimab |
| Control arm | Placebo comparator | Intravenous infusion (IV) of placebo at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival(PFS)
Evaluated according to RECIST 1.1 criteria by researchers.
Measured: up to 36 months
Secondary outcomes (5)
Overall Survival(OS)
Measured: up to 36 months
Progress Free Survival rate
Evaluated according to RECIST 1.1 criteria by researchers.
Measured: record in 12、18 and 24 months
Overall Survival rate
Evaluated according to RECIST 1.1 criteria by researchers.
Measured: record in 12、18 and 24 months
Objective response rate(ORR)
Evaluated according to RECIST 1.1 criteria by researchers.
Measured: up to 36 months
Disease control rate(DCR)
Evaluated according to RECIST 1.1 criteria by researchers.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Limited Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, MD, Sun Yat-sen University
- Investigators
- Li Zhang, MD, Principal investigator, Sun Yat-sen UniversityYan Huang, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623267
- Sponsor's protocol ID
- B2022-501-01
- Acronym
- SURPASS
- Status last verified
- Aug 2023
- First submitted
- 12 Nov 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
PubMed 28642008Welsh JW, Heymach JV, Guo C, Menon H, Klein K, Cushman TR, Verma V, Hess KR, Shroff G, Tang C, Skoulidis F, Jeter M, Comeaux N, Patel RR, Chen D, Ozgen T, Nguyen QN, Chang JY, Altan M, Zhang J, Papadimitrakopoulou VA, Simon GR, Byers LA, Glisson B. Phase 1/2 Trial of Pembrolizumab and Concurrent Chemoradiation Therapy for Limited-Stage SCLC. J Thorac Oncol. 2020 Dec;15(12):1919-1927. doi: 10.1016/j.jtho.2020.08.022. Epub 2020 Sep 8.
PubMed 32916308Nong J, Gong Y, Guan Y, Yi X, Yi Y, Chang L, Yang L, Lv J, Guo Z, Jia H, Chu Y, Liu T, Chen M, Byers L, Roarty E, Lam VK, Papadimitrakopoulou VA, Wistuba I, Heymach JV, Glisson B, Liao Z, Lee JJ, Futreal PA, Zhang S, Xia X, Zhang J, Wang J. Circulating tumor DNA analysis depicts subclonal architecture and genomic evolution of small cell lung cancer. Nat Commun. 2018 Aug 6;9(1):3114. doi: 10.1038/s41467-018-05327-w.
PubMed 30082701Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5. doi: 10.1200/JCO.1992.10.6.890.
PubMed 1316951Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403.
PubMed 9920950Acheampong E, Abed A, Morici M, Bowyer S, Amanuel B, Lin W, Millward M, Gray ES. Tumour PD-L1 Expression in Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Cells. 2020 Oct 31;9(11):2393. doi: 10.3390/cells9112393.
PubMed 33142852Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.
PubMed 33721560Haslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open. 2019 May 3;2(5):e192535. doi: 10.1001/jamanetworkopen.2019.2535.
PubMed 31050774Tan DS, Camilleri-Broet S, Tan EH, Alifano M, Lim WT, Bobbio A, Zhang S, Ng QS, Ang MK, Iyer NG, Takano A, Lim KH, Regnard JF, Tan P, Broet P. Intertumor heterogeneity of non-small-cell lung carcinomas revealed by multiplexed mutation profiling and integrative genomics. Int J Cancer. 2014 Sep 1;135(5):1092-100. doi: 10.1002/ijc.28750. Epub 2014 Apr 3.
PubMed 24482041The Lancet Oncology. Liquid cancer biopsy: the future of cancer detection? Lancet Oncol. 2016 Feb;17(2):123. doi: 10.1016/S1470-2045(16)00016-4. No abstract available.
PubMed 26868335Coakley M, Garcia-Murillas I, Turner NC. Molecular Residual Disease and Adjuvant Trial Design in Solid Tumors. Clin Cancer Res. 2019 Oct 15;25(20):6026-6034. doi: 10.1158/1078-0432.CCR-19-0152. Epub 2019 May 14.
PubMed 31088829Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
PubMed 29313949Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302.
PubMed 1331787Zhao S, Chen K, Shi X, Sun J, Fang W, Huang Y, Zhang L. Design and Rationale for a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-Stage Small-Cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy: The SURPASS Study. Clin Lung Cancer. 2023 Nov;24(7):e254-e258. doi: 10.1016/j.cllc.2023.06.009. Epub 2023 Jun 15.
PubMed 37442748
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT05623267
- Acronym / sponsor ID
- SURPASS / B2022-501-01
- Conditions
- Limited Stage Small Cell Lung Cancer
- Keywords
- Limited-stage Small-cell Lung Cancer（LS-SCLC）, Minimal Residual Disease（MRD）, Immunotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Nov 2022 (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.
The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.
Detailed description
This study is planned to enroll approximately 346 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to the experimental and control arm. The experimental arm would receive sugemalimab, while the control arm would receive placebo.Tumor assessment will be conducted using computed tomography/magnetic resonance imaging and MRD detection will be performed along with radiologic review during each visit. The above assessment will be conducted every 12 weeks for the first 2 years, every 24 weeks for the third year, and annually thereafter until confirmed disease progression per RECIST 1.1 or death.The primary endpoint is PFS ,which is defined as the time from the date of randomization to the date of disease progression (per RECIST 1.1), any cause of death, loss to follow-up, or initiation of new antitumor therapy, whichever occurred first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: SugemalimabIntravenous infusion (IV) of Sugemalimab 1200 mg at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity. |
| Control arm | Placebo comparator | Drug: PlaceboIntravenous infusion (IV) of placebo at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1、18 years or older. 2、Histologically or cytologically confirmed small cell lung cancer. 3、ECOG PS=0-1 at enrollment; 4、Limited-stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses).
- 5、Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses surgery.
- 6、Completion of 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy.
- 7、After the completion of concurrent or sequential chemoradiotherapy, prophylactic intracranial irradiation (PCI) is allowed based on the common practice of individual sites.
- 8、The start of concurrent radiotherapy should be no later than the last day of the second course of chemotherapy (the first day of the third cycle of chemotherapy). The interval between the end of chemotherapy cycle and beginning of radiotherapy must not exceed 35 days for sequential chemoradiotherapy.
Key exclusion criteria (11 listed)
- Histologically or cytologically diagnosed mixed small cell lung cancer or non-small cell lung cancer.
- Extensive-stage small cell lung cancer.
- Has malignant pleural or pericardial effusion.
- Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors.
- Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.
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 |
|---|---|---|
| SugemalimabRecombinant anti-PD-L1 fully human monoclonal antibody | Drug | Experimental arm |
| PlaceboPlacebo of Sugemalimab | Drug | Control arm |
Primary outcome
Progress Free Survival(PFS)
Time frame: up to 36 months
Evaluated according to RECIST 1.1 criteria by researchers.
5 secondary outcomes
Overall Survival(OS)
Time frame: up to 36 months
Progress Free Survival rate
Time frame: record in 12、18 and 24 months
Overall Survival rate
Time frame: record in 12、18 and 24 months
Objective response rate(ORR)
Time frame: up to 36 months
Disease control rate(DCR)
Time frame: up to 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 7 Aug 2023.
- Background: PubMed 28642008Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
- Background: PubMed 32916308Welsh JW, Heymach JV, Guo C, Menon H, Klein K, Cushman TR, Verma V, Hess KR, Shroff G, Tang C, Skoulidis F, Jeter M, Comeaux N, Patel RR, Chen D, Ozgen T, Nguyen QN, Chang JY, Altan M, Zhang J, Papadimitrakopoulou VA, Simon GR, Byers LA, Glisson B. Phase 1/2 Trial of Pembrolizumab and Concurrent Chemoradiation Therapy for Limited-Stage SCLC. J Thorac Oncol. 2020 Dec;15(12):1919-1927. doi: 10.1016/j.jtho.2020.08.022. Epub 2020 Sep 8.
- Background: PubMed 30082701Nong J, Gong Y, Guan Y, Yi X, Yi Y, Chang L, Yang L, Lv J, Guo Z, Jia H, Chu Y, Liu T, Chen M, Byers L, Roarty E, Lam VK, Papadimitrakopoulou VA, Wistuba I, Heymach JV, Glisson B, Liao Z, Lee JJ, Futreal PA, Zhang S, Xia X, Zhang J, Wang J. Circulating tumor DNA analysis depicts subclonal architecture and genomic evolution of small cell lung cancer. Nat Commun. 2018 Aug 6;9(1):3114. doi: 10.1038/s41467-018-05327-w.
- Background: PubMed 1316951Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5. doi: 10.1200/JCO.1992.10.6.890.
- Background: PubMed 9920950Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403.
- Background: PubMed 33142852Acheampong E, Abed A, Morici M, Bowyer S, Amanuel B, Lin W, Millward M, Gray ES. Tumour PD-L1 Expression in Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Cells. 2020 Oct 31;9(11):2393. doi: 10.3390/cells9112393.
- Background: PubMed 33721560Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12.
- Background: PubMed 31050774Haslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw Open. 2019 May 3;2(5):e192535. doi: 10.1001/jamanetworkopen.2019.2535.
- Background: PubMed 24482041Tan DS, Camilleri-Broet S, Tan EH, Alifano M, Lim WT, Bobbio A, Zhang S, Ng QS, Ang MK, Iyer NG, Takano A, Lim KH, Regnard JF, Tan P, Broet P. Intertumor heterogeneity of non-small-cell lung carcinomas revealed by multiplexed mutation profiling and integrative genomics. Int J Cancer. 2014 Sep 1;135(5):1092-100. doi: 10.1002/ijc.28750. Epub 2014 Apr 3.
- Background: PubMed 26868335The Lancet Oncology. Liquid cancer biopsy: the future of cancer detection? Lancet Oncol. 2016 Feb;17(2):123. doi: 10.1016/S1470-2045(16)00016-4. No abstract available.
- Background: PubMed 31088829Coakley M, Garcia-Murillas I, Turner NC. Molecular Residual Disease and Adjuvant Trial Design in Solid Tumors. Clin Cancer Res. 2019 Oct 15;25(20):6026-6034. doi: 10.1158/1078-0432.CCR-19-0152. Epub 2019 May 14.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- 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.
Li Zhang, MD principal investigator
Sun Yat-sen University
Yan Huang, MD principal investigator
Sun Yat-sen University
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 Sugemalimab in people with Limited Stage Small Cell Lung Cancer, run by Sun Yat-sen University 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 Aug 2023. 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. Some participants in this study may receive a placebo. 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 Shen Zhao, MD (+86-13570917392, zhaoshen@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival(PFS) (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623267, which also lists 15 linked publications.
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 7 Aug 2023.