Limited-stage small cell lung cancer without progression after standard concurrent chemoradiotherapy
Conditions
Interventions
control group:AK112 injection placebo
experimental group:AK112 Injection
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be able to understand and voluntarily sign a written ICF, which must be signed before performing the specified research procedures required for the study. 2. The age of the subject was >=18 years old on the day of signing ICF. 3. Eastern Cooperative Oncology (ECOG) performance status of 0 or 1. 4. Expected survival time >=3 months. 5. Histologically or cytologically confirmed small-cell lung cancer. 6. Limited stage defined by the American Joint Committee on Cancer Cancer Staging Manual (AJCC Cancer staging Manual, 8th edition, stage I-III, i.e., Tany, Nany, M0) and the American Legion Lung Cancer Society VALG staging system, that is, the patient's disease can be included in the radical radiotherapy field. T3-4 could not be included in a tolerable radiotherapy plan due to multiple lung nodules or large tumor/nodule size. Stage I or II participants had to be medically unable to undergo surgery (at the discretion of the investigator). 7. Receive standard cCRT regimens as defined below: a) receive four cycles of platinum-based and etoposide chemotherapy; b) For the standard once daily (QD) radiotherapy regimen, the total radiation dose received is 60-70 Gy, for each day The total radiation dose was 45 Gy in the second fraction (BID) protocol. Radiotherapy must be started no later than the end of the second course of chemotherapy. c) receipt of study drug within 42 days after last chemoradiotherapy. 8. Patients must achieve CR, PR, or SD without disease progression after definitive platinum-based cCRT. 9. Prophylactic cranial irradiation (PCI) was administered, at the investigator's discretion, only after completion of cCRT. 10. Have good organ function. 11. Within 7 days before the first dose, women of childbearing age must confirm a negative serum pregnancy test and agree to use effective contraception for the duration of study drug use and for 120 days after the last dose. In this scheme, women of childbearing age are defined as sexually mature women: 1) not undergoing hysterectomy or bilateral oophorectomy, 2) a non-continuous 24 months of spontaneous amenorrhea (amenorrhea after cancer treatment does not exclude fertility) (i.e., having had a period at any time in the previous 24 consecutive months). For male subjects whose sexual partner was a woman of reproductive age, consent was required during and after the last dose of the study drug Use of effective contraception within 120 days.
Exclusion criteria
Exclusion criteria: 1. Mixed SCLC and non-small cell lung cancer (NSCLC) components confirmed by histopathology or cytology. 2. Concurrent chemoradiotherapy (CCRT) : Patients received chemotherapy for more than 4 cycles, using chemotherapy regimens other than etoposide and platinum. He had received prior treatment with surgery, radiotherapy, or chemotherapy for limited-stage small-cell lung cancer in addition to cCRT. 3. Lack of resolution of toxicity from prior antineoplastic therapy, defined as failure to return to NCI CTCAE version 5.0 grade 0 or 1 or levels specified in the inclusion/exclusion criteria, with the exception of alopecia. Subjects with irreversible toxic effects (e.g., hearing loss) that were not expected to worsen after administration of the study drug may be included in the study after consultation with the sponsor. Patients with long-term radiation-induced toxicity or grade 2 or higher neuropathy who did not recover in the judgment of the investigator, after consultation with the sponsor, may be included in the study. 4. During the screening period, subjects had symptoms or signs of worsening of the primary disease that were deemed by the investigator to be clinically unacceptable, such as cachexia. 5. Imaging during the screening period showed that the tumor was surrounded by important blood vessels or had obvious necrosis or cavitation, and the investigator judged that the entry of the study would cause bleeding risk. 6. The tumor invades the surrounding important organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or there is a risk of esophagotracheal fistula or esophagopleural fistula. 7. Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring drainage. 8. Active malignancy within the previous 5 years. However, the tumors participating in the study and cured local tumors were excluded, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, localized prostate cancer, and micropapillary thyroid cancer. 9. History of esophagogastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose. 10. Acute exacerbation of chronic obstructive pulmonary disease within 1 month before the first dose. 11. History of severe bleeding tendency or coagulopathy; Clinically significant bleeding symptoms were present within 1 month before the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as the coughing up or exhalation of =1 teaspoon of blood or small blood clot or blood without sputum; patients with blood in sputum were allowed), and nasal bleeding (excluding epistaxis and retraction of rhinorrhea). 12. Major surgical procedure or trauma within 28 days before the first dose or planned within 28 days after the first dose (at investigator discretion). 13. Current uncontrolled comorbidities, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis and other related diseases. 14. Presence of severe neurological or psychiatric illness, including dementia, depression, and seizures. 15. Pregnant or lactating women; 16. Presence of any of the following cardiovascular or ce
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;metastasis-free survival;Pharmacokinetics;ADA;PD-L1;safety;objective response rate;duration of response; | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Cancer Hospital
Outcome results
None listed