Lung squamous cell carcinoma
Conditions
Interventions
Treatment Group (Single-arm):Iparomlimab and Tuvonralimab (QL1706) plus Docetaxel
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of a written informed consent form (ICF); 2. Age >= 18 years at enrollment, gender not restricted; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; 4. Expected survival period >= 3 months; 5. According to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer 8th edition of the lung cancer TNM staging classification, having histological or cytological confirmed incurable locally advanced (stage IIIA/IIIB/IIIC) or metastatic (stage IV) lung squamous cell carcinoma; 6. Only received one PD-1/PD-L1 inhibitor (including combined with one platinum-based double-drug chemotherapy), and after receiving PD-1/PD-L1 inhibitor (combined or not combined with chemotherapy) with clinical benefit, the disease progressed, including the following groups of patients: For patients with advanced lung squamous cell carcinoma who received only immunotherapy and achieved CR and PR (without duration limit), and SD >= 6 months, and then experienced disease progression; For patients with advanced lung squamous cell carcinoma who received chemotherapy combined with immunotherapy with clinical benefit PFS >= 3 months before disease progression can be enrolled; For patients who received a full course of immunotherapy and experienced PD after the last immunotherapy can be enrolled; Patients who received only immunotherapy as neoadjuvant treatment, those with recent response of CR/PR or postoperative pathology indicating complete pathological response (pCR)/major pathological response (MPR), regardless of whether they received adjuvant immunotherapy, can be enrolled if they have recurrence within 6 months after the last immunotherapy; For patients who received neoadjuvant treatment with chemotherapy combined with immunotherapy, only if the pathological assessment reaches pCR/MPR, regardless of whether they received adjuvant immunotherapy, can be enrolled if they have recurrence within 6 months after the last immunotherapy. (Notes: a) For patients in the neoadjuvant or adjuvant stage who received platinum-based chemotherapy treatment, if disease progression or recurrence occurs within 6 months after treatment, this treatment plan will be regarded as a platinum-based chemotherapy for locally advanced or metastatic lung squamous cell carcinoma; b) For patients in the neoadjuvant or adjuvant stage who received PD-1/PD-L1 inhibitor treatment, if disease progression or recurrence occurs within 6 months after treatment, this treatment plan will be regarded as PD-1/PD-L1 inhibitor treatment for locally advanced or metastatic lung squamous cell carcinoma; c) Patients who progressed after first-line PD-1/PD-L1 inhibitor treatment and then progressed with platinum-based chemotherapy can be enrolled; d) Patients who progressed after first-line platinum-based chemotherapy treatment and then progressed with immunotherapy monotherapy can be enrolled); 7. If the previous driver gene status is unknown, no corresponding test is required before enrolling in this study, and it is regarded as negative. 8. The subject must have at least one measurable lesion (according to RECIST v1.1 definition), and the lesion is suitable for repeated accurate measurement. If progression is confirmed, the previously untreated area without radiotherapy or the measurable lesion after non-local treatment can be selected as the target lesion. The enlarged lesion after radiotherapy or local treatment can also be se
Exclusion criteria
Exclusion criteria: Tumor-related characteristics and treatment 1. Histological or cytological pathology confirms the presence of small cell cancer components, or any driver gene-positive lung squamous cell carcinoma. 2. Subjects who have experienced disease progression after PD-1/PD-L1 inhibitor treatment and continue to use the original PD-1/PD-L1 inhibitor for 2 times or less can be enrolled. Subjects who continue to use other immunosuppressants for >= 2 times will be excluded; subjects who have previously received anti-CTLA-4 treatment are excluded. 3. Exclude those who have previously used docetaxel. 4. Exclude subjects who have received systemic treatment >= 2 lines. 5. Exclude subjects who received the last systemic anti-tumor treatment (chemotherapy, immunotherapy) within 3 weeks before the first administration. 6. Exclude subjects who received the following treatments within 2 weeks before the first administration: TKI treatment, hormone anti-tumor treatment, palliative local treatment for non-target lesions, non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for treating thrombocytopenia); subjects who received traditional Chinese medicine or herbal medicine with anti-tumor indications within 1 week before the first administration. 7. Exclude subjects who have received radiotherapy to the radiation field that has involved the heart (such as chest radiotherapy, etc.). 8. Subjects with tumor invasion surrounding important blood vessels or with obvious necrosis and cavities, and the investigator determines that entering the study will cause bleeding risk. 9. Anti-tumor biological therapy or major surgery within 3 weeks before the administration of the first study drug. 10. Exclude subjects whose imaging shows tumor invasion of surrounding important organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or with the risk of developing esophageal-tracheal fistula or esophageal-pulmonary fistula. 11. Have symptomatic central nervous system metastasis; for patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases and >= 2 weeks since the last administration, as long as all of the following criteria are met, they can participate in this study: no brainstem, midbrain, pons, cerebellum, medulla oblongata, spinal cord metastasis or spinal cord compression; no history of intracranial hemorrhage; more than 2 weeks have passed since stopping hormone treatment before the first administration; no obvious edema around the brain metastasis lesion; the long diameter of the brain metastasis lesion is > 1.5 cm. 12. Subjects who have experienced any of the following situations during PD-1/PD-L1 inhibitor treatment in the past: - Experienced grade 3 or above immune-related adverse reactions (irAE) caused by PD-1/PD-L1 inhibitor treatment (excluding endocrine system-related irAE), resulting in permanent discontinuation of treatment, grade 2 immune-related cardiac toxicity, or any grade of neurological or ocular irAE. - Before the screening of this study, all adverse events during the previous PD-1/PD-L1 inhibitor treatment have not been completely resolved to grade 1 or have subsided (excluding alopecia and sensory nerve lesions). For subjects with >= 2 grade 2 adverse endocrine events, if the condition is stable after appropriate alternative treatment and there are no symptoms, they are allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Duration of Response (DoR);Disease Control Rate (DCR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed