Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University

About this trial

In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.

Eligibility criteria

Qualifiers

Pathologically (histologically or cytologically proven) NSCLC. Tumors with any component of small cell lung cancer are not allowed.

AJCC 8th edition clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease. Stage IA1 tumors are excluded unless recurrent with radiographic solid component -or- pathologic invasive component of > 10 mm.

Received curative intent therapy with surgery and/or radiation. Note: May have received chemotherapy.

Completed all intended therapy (surgery, radiation, and/or chemotherapy) - AND- no more than 32 weeks has elapsed after the last day of this therapy.

Disqualifiers

Involvement in the planning and/or conduct of the study

History of Grade 3 or higher pneumonitis from prior radiation; patients with grade 2 radiation pneumonitis may be considered for enrollment with permission from the Protocol Director or Co-Director.

History of another primary malignancy and currently undergoing active treatment Exception: May participate if receiving adjuvant endocrine therapy for breast or prostate cancer.

Expected to require ongoing chronic treatment with systemic immunosuppressive medication after enrollment.

Trial design

Treatments tested in this trial

  • AVENIO ctDNA Surveillance Kit
  • Durvalumab
  • Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Stanford University

Lead sponsor

AstraZeneca

Collaborator