Neoadjuvant Durvalumab and Chemotherapy Followed by Surgery/CRT and Durvalumab in Borderline Rese… (NCT06998719) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Durvalumab and Chemotherapy Followed by Surgery/CRT and Durvalumab in Borderline Resectable Stage III NSCLC
China80 participantsStarted 2025-07
Plain-language summary
A Phase II, interventional study of neoadjuvant durvalumab (MEDI 4736) and platinum-based Chemotherapy, followed by either surgery and adjuvant durvalumab or chemoradiotherapy (CRT) and consolidation durvalumab, in participants with borderline resectable stage III Non-small Cell Lung Cancer (NSCLC) (ACCESS)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Nodal status should be investigated with whole body FDG-PET, plus contrast-enhanced computed tomography, and it is optional and decided by investigator that nodal status be proven by biopsy via endobronchial ultrasound, mediastinoscopy, or thoracoscopy.
✓. Mandatory brain MRI with IV contrast, if not available, it is mandatory to take brain computed tomography with IV contrast at the time of staging.
✓. Females \< 50 years old are considered post-menopausal if they have been amenorrhoeic for 12 months or more prior to enrolment following cessation of exogenous hormonal treatment and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
✓. Females ≥ 50 years old are considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment, or had radiation-induced menopause with last menses \> 1 year ago, or had chemotherapy-induced menopause with last menses \> 1 year ago.
✓. Female participants of child-bearing potential must agree to use at least one highly effective method of birth control (see Appendix G for complete list of highly effective birth control methods). They should have been stable on their chosen method of birth control for a minimum of 3 months prior to enrollment (screening), while receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents. Cessation of birth control after this point should be discussed with a responsible physician.
✓. Non-sterilised male partners of a female participant of child-bearing potential must use a male condom plus spermicide (condom alone in countries where spermicides are not approved) from the time of screening their female partner, while their female partner is receiving study intervention, SoC Chemotherapy or CRT, and for 90 days after the last dose of durvalumab and for periods specified in the local prescribing information/SmPC relating to contraception and the time limit for such precautions for SoC agents.
What they're measuring
1
Resection rate
Timeframe: Through study completion, an average of 1 year.
✓. Periodic abstinence, as well as the rhythm and withdrawal methods are not acceptable methods of birth control..
Exclusion criteria
✕. Existence of more than one primary tumor, such as: mixed small cell and NSCLC histology; synchronous or metachronous tumors that could represent distinct primary tumors.
✕. History of another primary malignancy except for malignancy treated with curative-intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy or adequately treated carcinoma in situ without evidence of disease.
✕. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves ' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune pneumonitis, and autoimmune myocarditis). The following are exceptions to this criterion:
✕. Known active hepatitis infection, positive HCV antibody, HBsAg or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Participants co-infected with HBV and HCV, or co-infected with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti-HBcAb with detectable HBV DNA); AND
✕. Known to have tested positive for HIV (positive HIV 1 or 2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
✕. History of active primary immunodeficiency.
✕. Investigator judgement of one or more of the following:
✕. Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.