Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed & Carboplatin (PC) for Metastatic Non-Squamous NSCLC

Stopped early · Phase 2

Conditions studied: Non-Small Cell Lung Cancer Metastatic

In brief

This is a Phase II, open label, randomized study of durvalumab in combination with pemetrexed and carboplatin in eligible adult patients with locally advanced or metastatic non-small cell lung cancer. The study will focus on the efficacy of two alternative staggered dosing regimens.

Key facts

Study ID

NCT04163432

Run by

University of Utah

People needed

43

Starts

2020-06-18

Expected to finish

2026-02-23

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subject aged ≥ 18 years.
• Histologically or cytologically confirmed lung cancer.
• Metastatic non-squamous non-small cell lung cancer.
• Body weight >30kg
• Patient has measurable disease as defined by RECIST 1.1 as assessed by either CT or MRI.
• Chemoimmunotherapy naïve (including durvalumab).
• ECOG Performance Status ≤ 2.
• Note: If performance status = 2, ensure that there is a slot available prior to registration as only 20 PS = 2 patients will be enrolled on the protocol.
• Must have a life expectancy of at least 12 weeks.
• Adequate organ function as defined as:
• Hematologic:
• White blood cell count > 2.0 g/dL
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 9 g/dL
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Hepatic:
• Total Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• Except for patients with Gilbert's syndrome.
• AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN or ≤ 5 × institutional ULN if liver metastases are present
• Renal:
• eGFR ≥ 30 mL/min/1.73m2 or creatinine clearance ≥ 30 mL/min by Cockcroft-Gault:
• Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
• Females: (((140-age)×weight[kg])/(serum creatinine [mg/dL]×72))×0.85
• FOR PATIENTS ENROLLED PRIOR TO AMENDMENT V18MAR2024: Concurrent enrollment in the study, "Rethinking Measurement of Performance Status in Cancer Patients," IRB 112529 or the patient declined participation.
• FOR PATIENTS ENROLLED PRIOR TO AMENDMENT V18MAR2024: Concurrent enrollment in the study, "An Observational Study Assessing the Clinical Effectiveness of the VeriStrat® Test and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer," IRB 100314 or the patient has declined participation.

You may not qualify if…

• ALK or EGFR non-squamous non-small cell lung cancer.
• Prior radiation therapy within 2 weeks prior to cycle one day one.
• Exception: Prior palliative radiotherapy is permitted, provided it has been completed at least 2 days prior to study enrollment and no clinically significant toxicities are expected.
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
• Note: Local surgery of isolated lesions for palliative intent is acceptable.
• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis,uveitis, etc]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with endocrine disorders with controlled disease on hormone replacement therapy (e.g. adrenal, thyroid, or pituitary replacement therapy)
• 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 principal investigator
• Patients with celiac disease controlled by diet alone
• Current or prior use of immunosuppressive medication within 14 days of cycle one day one, EXCEPT for the following permitted steroids:
• Intranasal, inhaled, topical steroids, eye drops or local steroid injection (eg,intra-articular injection);
• Systemic corticosteroids at physiologic doses ≤ 10mg/day of prednisone or equivalent;
• Steroids as premedication for hypersensitivity reactions (eg, computed tomography (CT) scan premedication).
• Other immunosuppressive agents which, in the opinion of the investigator, are not expected to significantly impact study participation or the mechanism of action of the study therapy.
• History of active primary immunodeficiency
• Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, and low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (eg, surgery, radiation, or castration) or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms is allowed.
• Uncontrolled CNS metastases. Subjects with previously treated brain metastases will be allowed if the brain metastases have been treated, toxicities have resolved to grade 1 or baseline and steroids are no longer required.
• -Note: Patients with asymptomatic brain metastasis are allowed if previous steroid treatment was discontinued for 5 half-lives.
• History of leptomeningeal carcinomatosis
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
• Known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load 12 months, CD4+ count of ≥ 350 cells/uL, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 1 month on the same anti HIV medications.
• Active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).

Where it is running

• Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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