Health Trials

Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])

ConditionsLung Non-Small Cell CarcinomaLung Non-Small Cell Squamous CarcinomaLung Non-Squamous Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage IIIA Lung Cancer AJCC v8Stage IIIB Lung Cancer AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.

Eligibility criteria

Qualifiers

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)

Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)

Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Carboplatin
  • Cisplatin
  • Computed Tomography
  • Echocardiography Test
  • Gemcitabine Hydrochloride
  • Magnetic Resonance Imaging
  • Observation Activity
  • Paclitaxel
  • Pembrolizumab
  • Pemetrexed Disodium
  • Questionnaire Administration

Treatment groups

1,210 Participants
are divided into 3 treatment groups

Locations

1,150
Guam
FHP Health Center-Guam96913, Tamuning Guam
United States
Alaska
Alaska Breast Care and Surgery LLC99508, Anchorage United States
Alaska Oncology and Hematology LLC99508, Anchorage United States
Alaska Women's Cancer Care99508, Anchorage United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov