WithdrawnPhase 2

MEDI4736 With Selumetinib for KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

Stopped: Inadequate funding

0Started 2018-05

Plain-language summary

The goal of this clinical research study is to learn if MEDI4736 given in combination with selumetinib can help to control advanced lung cancer. The safety of this drug combination will also be studied.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed recurrent non-small cell lung cancer not amendable to curative intent therapy or stage IV NSCLC.
✓. Known KRAS mutation status by CLIA certified test. Patients in the safety run-in are not required to have a tumor with mutant KRAS. In the randomized portion of the trial, only patients with KRAS mutation are eligible.
✓. Documented progression following at least one line of chemotherapy for metastatic or recurrent disease, or progression within 6 months of receiving adjuvant chemotherapy or concurrent chemotherapy for early stage or locally advanced disease.
✓. Biopsy accessible disease and willingness to undergo tumor biopsy.
✓. Measurable disease by RECIST 1.1.
✓. Age\>/= 18 years.
✓. ECOG performance status 0 or 1.
✓. Ability to take pills by mouth.

Exclusion criteria

✕. Have received or are receiving an investigational medicinal product (IMP) or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment, or within a period during which the IMP or systemic anticancer treatment has not been cleared from the body (e.g. a period of 5 'half-lives'), whichever is the most appropriate and as judged by the investigator.
✕. Current or prior use of immunosuppressive medication within 14 days of the 1st dose of durvalumab, with the exception of intranasal and inhaled corticosteroids or oral corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
✕. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
✕. Receipt of radiation therapy within 4 weeks prior to starting study treatment. Limited field of radiation for palliation at any time prior to the start of study treatment is acceptable if: i.) The lung is not in the radiation field ii.) The irradiated lesions are not used as target lesions.
✕. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab.
✕. Prior treatment with a MEK, Ras, or Raf inhibitor, or CTLA4 inhibitor.
✕. Patients who are receiving any other investigational agents.
✕. Have any unresolved chronic toxicity with CTCAE grade \>/= 2, from previous anticancer therapy, except for alopecia.

What they're measuring

Progression Free Survival

Timeframe: 42 months

Trial details

NCT IDNCT03004105

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05

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