Neoadjuvant Durvalumab and Chemotherapy Followed by Surgery/CRT and Durvalumab in Borderline Resectable Stage III NSCLC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBi Nan

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Participant must be ≥ 18 years, at the time of screening. 2. Histologically or cytologically documented NSCLC. 3. Deemed borderline resectable at baseline, confirmed by MDT evaluation at diagnosis.

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.

Haemoglobin ≥ 9.0 g/dL.

Disqualifiers

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.

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

HCV positive (presence of anti-HCV antibodies); OR

Trial design

Design model

Parallel

Treatments tested in this trial

  • Durvalumab

    Drug

    Neoadjuvant durvalumab (MEDI 4736)and platinum-based chemotherapy, followed by either surgery and adjuvant durvalumab or CRT and consolidation durvalumab, in borderline resectable stage III NSCLC

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort 1 (Surgery)Experimental treatment 1 intervention
Group B: Cohort 2 (CRT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Resection rate

To assess the efficacy of neoadjuvant durvalumab + chemotherapy in terms of resection rate in participants with borderline resectable stage III NSCLC.

Time frame
Through study completion, an average of 1 year.

Secondary outcomes

1

R0 resection rate.

To investigate surgical outcomes.R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.R0 resection rate =The number of subjects whose lesions were completely removed/the number of subjects who participated in the surgery

Time frame
Through study completion, an average of 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bi Nan

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator

This trial is not recruiting at the moment. You can still explore other options: