Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer
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.
Interventions
Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.
Sponsors
Hunan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | From the initiation of the first dose to 3 years | Objective response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From the initiation of the first dose to 3 years | Overall survival |
| iORR | From the initiation of the first dose to 3 years | Objective response rate after induction therapy |
| 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 |
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactHuai Liu, MD
Outcome results
None listed