Determining Whether Durvalumab in Combination With Radiation Therapy Can Prevent the Progression of Non-Small Cell Lung Cancer

NCT03999710 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 19-218
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to see if Durvalumab and radiation therapy can delay the worsening of disease in patients with non-small cell lung cancer normally treated with sequential chemotherapy followed by radiation therapy.

Conditions

Non Small Cell Lung Cancer; Lung Cancer; Nsclc; NSCLC Stage II; NSCLC, Stage III

Keywords

Lung Cancer; Non Small Cell Lung Cancer; Radiation therapy; durvalumab; 19-218; Memorial Sloan Kettering Cancer Center; newly diagnosed; recurrent

Outcome Measures

Primary Outcomes (1)

• 2-year PFS rate

  Demonstrate an improvement in 2-year PFS rate compared to historical results.

  2 years

Study Arms (1)

Non-Small Cell Lung Cancer

EXPERIMENTAL

All participants have locally-advanced non-small cell lung cancer, Stage II-III. Treatment will consist of durvalumab administered concurrently with thoracic radiation consisting of 60 Gy in 30 fractions. Patients will be monitored weekly during on-treatment visits. Durvalumab will then be continued up to 1 year as maintenance or until disease progression or unacceptable toxicity. Optional Research MRIs (Does not apply to the Alliance Sites. Research MRIs will only be done at MSKCC)

Radiation: Radiation Therapy; Drug: Durvalumab

Interventions

Radiation Therapy RADIATION

Treatment will consist of 60 Gy in 30 fractions to fields encompassing gross tumor and lymph nodes.

Non-Small Cell Lung Cancer

Durvalumab DRUG

A dose of 1500mg (for patients \>30kg in weight) will be administered using an IV bag containing 0.9% (w/v) saline or 5% (w/v) dextrose, with a final durvalumab concentration ranging from 1 to 15 mg/mL, and delivered through an IV administration set with a 0.2- or 0.22- μm filter.

Non-Small Cell Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Patient age \>/= 18 at time of consent
• Newly diagnosed or recurrent Locally-advanced NSCLC (stage II-III) amenable for treatment with concurrent definitive radiation and durvalumab
• Ineligible for resection and concurrent CRT as determined by one of the following reasons: Medically inoperable, surgically unresectable (including N3 nodal disease), medically unfit or unsafe for chemotherapy, or other reason deemed appropriate by the investigator and approved by PI.
• Note: The reason a patient is deemed ineligible for concurrent CRT must be documented (i.e. hearing impairment, neuropathy, renal dysfunction, symptomatic/advanced underlying medical comorbidities, etc.)
• Histological and/or cytological confirmation of NSCLC (both squamous and adenocarcinoma) as per standard of care biopsy; no additional research protocol-specific biopsy is needed.
• ECOG/WHO PS 0-2
• Candidates for definitive RT to 60 Gy in 30 fractions
• Body weight \> 30kg
• Adequate normal organ and marrow function as defined below:
• Hemoglobin \>/= 9.0 g/dL
• Absolute neutrophil count (ANC) 1.5 x (\>/= 1500 per mm3)
• Platelet count \>/= 75 x 10\^9/L (\>/= 75,000 per mm3)
• Serum bilirubin \</= 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
• AST (SGOT)/ALT (SGPT) \</= 2.5 x institutional upper limit of normal

You may not qualify if:

• Participants in another clinical study with an investigational product during the last 4 weeks
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Previous thoracic radiation precluding definitive RT
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], acute diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with the study physician
• Patients with celiac disease controlled by diet alone
• Patients with Grade \>/= neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
• Prior/Current Therapies
• Treatment with a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered (i.e., \>/= Grade 1 at baseline) from adverse events due to agents administered \> 4 weeks earlier (intraocular bevacizumab is acceptable)
• Prior chemotherapy or targeted small molecule therapy, within 3 weeks prior to study Day 1 or has not recovered (i.e., \>/= Grade 1 at baseline) from adverse events due to a previously administered agents (excluding Grade 2 peripheral neuropathy)
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLAA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (9)

Baptist Alliance Miami Cancer Institute

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Recurrence

Interventions

Radiotherapy; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Narek Shaverdian, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: July 19, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (9)