A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

Phase 2

Recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Sugemalimab and Chemotherapy

• Registration Number: NCT05940532
• Lead Sponsor: Hunan Cancer Hospital

Brief Summary

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-14
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-07
• Last Update Submitted: 2023-07-07
• Study First Posted: 2023-07-11
• Last Update Posted: 2023-07-11
• Primary Completion: 2025-01
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1.18 to 75 years old, both male and female;

2.ECOG score: 0-1;

3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;

4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;

5.Measurable lesions available;

6.Major organ function is basically normal;

7.Estimated survival time is at least 6 months;

8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.

Exclusion Criteria

1. Histologically or cytologically confirmed mixed SCLC and NSCLC;
2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
4. Previous thoracic radiotherapy;
5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
6. Systemic immunostimulant therapy before the first dose;
7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
8. Subjects with autoimmune diseases;
9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
10. Known or suspected interstitial pneumonia;
11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
12. Severe cardiovascular and cerebrovascular diseases;
13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
14. Arteriovenous thrombotic events within 3 months before the first dose;
15. Positive HIV test;
16. Active hepatitis B or C;
17. Evidence of active tuberculosis infection within 1 year before the first dose;
18. Serious infection within 4 weeks before the first dose;
19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
22. History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
23. Allergic to any component of the randomized treatment regimen;
24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional arm	Sugemalimab and Chemotherapy	Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy.

Primary Outcome Measures

Name	Time	Method
ORR	From the initiation of the first dose to 3 years	Objective response rate

Secondary Outcome Measures

Name	Time	Method
OS	From the initiation of the first dose to 3 years	Overall survival
AEs	From the initiation of the first dose to 90 days after the last dose	Adverse events
PFS	From the initiation of the first dose to 3 years	Progression-free survival
iORR	From the initiation of the first dose to 3 years	Objective response rate after induction therapy
Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire	From the initiation of the first dose to 3 years	The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine"
Measurement of Quality of Life with EORTC QLQ-C30 questionnaire	From the initiation of the first dose to 3 years	EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome
Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire	From the initiation of the first dose to 3 years	EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, China