Induction chemoimmunotherapy plus chemoradiotherapy and consolidation immunotherapy in unresectable locally advanced NSCLC
Official title: A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Induction Chemoimmunotherapy Followed by Concurrent Chemoradiotherapy and Consolidation Immunotherapy in Unresectable Locally Advanced Non-Small Cell Lung Cancer
Run by Shanghai Chest Hospital · NCT07632365 · Data updated 2026-11-12
This trial tests induction chemoimmunotherapy followed by chemoradiotherapy and consolidation immunotherapy in adults with unresectable stage III NSCLC to see if it can improve outcomes compared with the standard PACIFIC approach.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Shanghai Chest Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone, radiation |
| Locations | 1 site (Shanghai, Xuhui) |
| Status | Recruiting |
| Started | October 9, 2022 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT07632365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with unresectable stage III NSCLC, ECOG 0-1, no prior anti-tumor therapy, and adequate organ function.
✕Probably not a fit
Patients who do not tolerate induction chemoimmunotherapy or do not meet safety criteria may not gain benefit and could experience added toxicity.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PIVOT is a multicenter phase I/II study evaluating a two-part treatment strategy for unresectable locally advanced NSCLC. In phase I, a single-arm safety lead-in tests induction chemoimmunotherapy with acceptable safety. If safety criteria are met, phase II randomizes participants 1:1 to receive either induction chemoimmunotherapy followed by concurrent chemoradiotherapy and consolidation immunotherapy or the standard PACIFIC regimen. The goal is to determine whether the investigational sequence improves progression-free survival while maintaining manageable safety. The standard of care for this setting is chemoradiotherapy followed by consolidation immunotherapy, but disease recurrence remains high and long-term control is incomplete. Induction therapy may reduce tumor burden and enhance subsequent radiotherapy and immune activation, potentially improving outcomes.
Why it matters
Potential benefit: If successful, patients could experience longer progression-free survival and potentially improved overall outcomes with a new, potentially more effective treatment sequence.
How similar studies have gone: Prior strategies combining chemoradiotherapy with consolidation immunotherapy have shown benefits, but this induction-then-consolidation approach is novel and under investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years, male or female, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 3. Unresectable stage III NSCLC (according to the 8th edition of the AJCC staging system). 4. No prior exposure to any other anti-tumor therapy. 5. Absence of severe medical comorbidities or major organ dysfunction, as assessed by hematology, hepatic, renal, cardiac, and pulmonary function tests, meeting the following criteria: Hematology: Hemoglobin (HB) ≥ 90 g/L (without blood transfusion within 14 days prior to enrollment); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L. Biochemistry: Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; serum creatinine (Cr) ≤ 1 × ULN, with an endogenous creatinine clearance rate \> 60 mL/min (calculated using the Cockcroft-Gault formula). Coagulation: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is receiving anticoagulant therapy, in which case PT or aPTT must be within the expected therapeutic range for the anticoagulant used). 6. Life expectancy ≥ 3 months. 7. Adequate understanding of the study, ability to complete treatment, suitability for follow-up, and voluntary provision of written informed consent. Exclusion Criteria: 1. Presence of small cell carcinoma components in the histological examination results. 2. Co-occurrence of EGFR mutation, ALK rearrangement, or ROS-1 rearrangement positivity. 3. History of other primary malignancies, with the following exceptions: Malignancies treated with curative intent with no known active disease and low potential for recurrence for ≥5 years prior to the first dose of investigational product (IP); adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease. 4. Active or documented history of autoimmune or inflammatory diseases (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[excluding diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, granulomatosis with polyangiitis \[Wegener's syndrome\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.). 5. History of allogeneic organ transplantation. 6. History of active primary immunodeficiency. 7. Presence of uncontrolled concurrent illness, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus \[HIV\], etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease (ILD), severe chronic gastrointestinal disease associated with diarrhea, or psychiatric disorders/social situations that would limit compliance with study requirements, substantially increase the risk of adverse events (AEs), or compromise the patient's ability to provide written informed consent. 8. Female patients who are pregnant or breastfeeding. 9. Concurrent or prior use of immunosuppressive medication within 14 days prior to the first dose of induction immunotherapy. Exceptions include: intranasal, inhaled, or topical corticosteroids, or local corticosteroid injections (e.g., intra-articular injection); systemic corticosteroids at physiological doses not exceeding 10 mg/day of prednisone or its equivalent; corticosteroids as prophylactic premedication for hypersensitivity reactions (e.g., premedication for computed tomography \[CT\] scan); or systemic corticosteroid administration administered as part of chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC), or administered prophylactically or for the management of toxicity induced by chemotherapy and/or radiotherapy. 10. Known allergy or hypersensitivity to any study drug or any excipient of a study drug. 11. Patients judged by the investigator to be unable to comply with study procedures, restrictions, and requirements.
Where it's running
-
Shanghai Chest Hospital
Shanghai, Xuhui, China Recruiting
Study contacts
- Study coordinator: Wen Yu, MD
- Email: yuzhiwen0827@163.com
- Phone: 021-22200000-3203
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.