NSCLC (Advanced Non-small Cell Lung Cancer)
Conditions
Brief summary
This is a randomized, controlled, multicenter clinical study that enrolled patients with unresectable bulky stage III NSCLC, with PFS as the primary endpoint. The study aims to investigate the efficacy and safety of adebrelimab combined with chemoradiotherapy in the treatment of locally advanced/unresectable stage III non-small cell lung cancer.
Interventions
DRUGAfter chemoimmunotherapy induction, followed by concurrent/sequential chemoradiotherapy and subsequent immune consolidation and maintenance therapy.
Patients receive adebrelimab combined with chemotherapy for 2 cycles of induction therapy, followed by sequential/concurrent chemoradiotherapy (sCRT/cCRT), and then undergo adebrelimab monotherapy for consolidation treatment. adebrelimab: 1200 mg iv, q3w Radiation therapy: Total dose of 60 Gy ± 10% (range: 54 Gy - 66 Gy). Chemotherapy: Regimens will be administered in accordance with guideline recommendations. Subsequently, patients will receive adebrelimab monotherapy as consolidation treatment, with each treatment cycle lasting 3 weeks. Treatment will be continued until disease recurrence or metastasis, intolerable toxicity, subject's voluntary withdrawal, or investigator's decision to discontinue the subject from the study.
DRUGadebrelimab,Radiation Therapy,Radiotherapy
Receive cCRT/sCRT followed by maintenance immunotherapy. adebrelimab: 1200 mg iv, q3w Radiation therapy: Total dose of 60 Gy ± 10% (range: 54 Gy - 66 Gy). Chemotherapy: Regimens will be administered in accordance with guideline recommendations. Subsequently, patients will receive adebrelimab monotherapy as consolidation treatment, with each treatment cycle lasting 3 weeks. Treatment will be continued until disease recurrence or metastasis, intolerable toxicity, subject's voluntary withdrawal, or investigator's decision to discontinue the subject from the study.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 75 years; * ECOG performance status score of 0 or 1; * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); * Unresectable stage III NSCLC (per AJCC 9th edition staging), with primary tumor diameter T ≥ 5 cm or regional metastatic lymph node short-axis diameter N ≥ 2 cm; * Expected survival time of at least 3 months; * No prior anti-tumor treatment before enrollment, including radiotherapy, chemotherapy, surgery and targeted therapy; * Adequate function of major organs; * Female subjects must have a negative pregnancy test result and be willing to use effective contraception; * Subjects voluntarily participate in the study, sign the informed consent form, with good compliance and willingness to complete follow-up.
Exclusion criteria
* Subjects with known positive EGFR mutation or positive ALK fusion. * Histologically or cytologically confirmed mixed SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcomatoid carcinoma. * Participation in another clinical trial within 4 weeks prior to the first study dose or within 5 half-lives of the study drug, whichever is shorter. * Subjects who have received systemic immunosuppressive therapy within 2 weeks before the first dose, or those who are expected to require systemic immunosuppressive drugs during the study treatment period. * Subjects with congenital or acquired immunodeficiency, such as HIV infection; or with a history of autoimmune diseases. * Active hepatitis B, hepatitis C, or co-infection with both hepatitis B and hepatitis C. * Uncontrolled third-space effusions, such as massive pleural effusion, ascites or pericardial effusion. * History of other malignant tumors (other than NSCLC) within 5 years prior to screening. * Subjects with prior interstitial lung disease requiring hormone therapy. * Subjects with severe cardiovascular and cerebrovascular diseases. * History of severe bleeding events or arterial/venous thromboembolic events. * Severe infection within 4 weeks before the first dose; evidence of active tuberculosis infection within 1 year prior to the first dose; active fungal, bacterial and/or viral infections requiring systemic treatment. * Subjects with prior or planned allogeneic bone marrow transplantation or solid organ transplantation. * History of live attenuated vaccination within 28 days before the first dose, or planned live attenuated vaccination during the study period; pregnant or lactating women; fertile patients who are unwilling or unable to adopt effective contraceptive measures. * Known hypersensitivity, anaphylactic reaction or intolerance to adebrelimab, chemotherapy agents, or their excipients. * Subjects with a known history of psychoactive substance abuse, alcoholism or drug addiction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From enrollment to the end of monitoring at 1.5 years. | PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From enrollment to the end of monitoring at 1.5 years. | OS is defined as the time from the first dose of study treatment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up. |
| Objective Response Rate (ORR) | From enrollment to the end of monitoring at 1.5 years. | ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1. |
| Duration of Response (DoR) | From enrollment to the end of monitoring at 1.5 years. | DoR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death. |
| The incidence of adverse events | From enrollment to the end of monitoring at 1.5 years | Incidence, nature, and severity of adverse events (AEs), graded according to NCI-CTCAE v6.0, including immune-related AEs and serious AEs. |
| Time to Death or Distant Metastasis（TTDM） | From enrollment to the end of monitoring at 1.5 years | From randomization/enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first. |
Countries
China
Contacts
CONTACTZhijie Wang, MD
Outcome results
None listed