Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a Phase II study to evaluate the clinical efficacy and safety of Toripalimab combined with chemoradiotherapy for large-volume local advanced non-small cell lung cancer

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Toripalimab Plus Radiotherapy in Patients With Operable Stage II-IIIA (N+) Non Small Cell Lung Cancer

NCT05798845

NSCLC

RECRUITING PHASE2

Neoadjuvant Immunotherapy in Rare Mutations Localized NSCLC

NCT05800340

Non-Small Cell Lung Cancer RET Driver Mutation BRAF V600 Mutation +3 more

RECRUITING PHASE2

Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC

NCT05055583

NSCLC Stage IV Oligometastasis

UNKNOWN PHASE2

Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer

NCT01494558

Non-Small Cell Lung Cancer

COMPLETED PHASE2/PHASE3

Study of Toripalimab for Limited-Stage Small Cell Lung Cancer Following Concurrent Chemoradiotherapy

NCT04418648

Small Cell Lung Cancer Limited Stage

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a Phase II study to evaluate the clinical efficacy and safety of two cycles of induction Toripalimab plus chemotherapy followed by definitive chemoradiotherapy and consolidation Toripalimab therapy for large-volume, unresectable, locally advanced stage II-III non-small cell lung cancer ("large volume" is defined as primary tumor ≥5 cm in greatest dimension or metastatic lymph nodes ≥2 cm in shortest diameter).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Local Advanced Non-small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy

Participants will receive 2 cycles of induction therapy of platinum-based chemotherapy combined with Toripalimab, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.

Group Type EXPERIMENTAL

Toripalimab

Intervention Type DRUG

Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet chemotherapy as induction chemoimmunotherapy.

Concurrent chemoradiation therapy and consolidation immunotherapy

Intervention Type RADIATION

Thoracic radiation therapy (54-66Gy/25-33F/5-7week), concurrently with platinum-based doublet chemotherapy, followed by consolidation Toripalimab (240mg every 3 weeks) as consolidation immunotherapy for up to 12 months.

Induction chemotherapy followed by concurrent chemoradiotherapy

Participants will receive 2 cycles of induction platinum-based chemotherapy, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.

Group Type ACTIVE_COMPARATOR

Concurrent chemoradiation therapy and consolidation immunotherapy

Intervention Type RADIATION

Thoracic radiation therapy (54-66Gy/25-33F/5-7week), concurrently with platinum-based doublet chemotherapy, followed by consolidation Toripalimab (240mg every 3 weeks) as consolidation immunotherapy for up to 12 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Toripalimab

Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet chemotherapy as induction chemoimmunotherapy.

Intervention Type DRUG

Concurrent chemoradiation therapy and consolidation immunotherapy

Thoracic radiation therapy (54-66Gy/25-33F/5-7week), concurrently with platinum-based doublet chemotherapy, followed by consolidation Toripalimab (240mg every 3 weeks) as consolidation immunotherapy for up to 12 months.

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tuo Yi The PACIFIC regimen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18-70 years; ECOG score 0-2.
2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
3. Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes.
4. No other previous anti-tumor history, at least 3 months of expected survival.
5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Exclusion Criteria

1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
2. Patients with other active malignancies within 5 years or at the same time.
3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
4. History of allogeneic organ transplantation.
5. History of active primary immunodeficiency.
6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness.
7. Women of child-bearing potential who are pregnant or breastfeeding.
8. Allergic to research drug ingredients.
9. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose
10. The investigator judged other situations not suitable for inclusion in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No