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


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Trial ID: NCT04585477


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.

Official Title

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

Stanford Investigator(s)

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)


Inclusion Criteria

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

   Adenocarcinoma patients must NOT be positive for EGFR Exon 19 deletion or L858R
   mutation, or ALK or ROS1 rearrangement.

   2. 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.

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

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

   5. No known current radiographic or pathologic residual/recurrent disease (in the
   investigator's opinion) after completion of all intended therapy (for example,
   positive margins after surgery without adjuvant radiotherapy, or unequivocal
   radiographic evidence of residual or recurrent disease)

   6. Pre-treatment tumor tissue or tumor DNA sample is believed to be available for

   7. Not received immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies) or be intended to
   receive immunotherapy, apart from this study.

   8. Not received another systemic anti-cancer investigational product during the 4 weeks
   prior to enrollment.

   9. Aged 18 years or older

10. ECOG Performance Status of 0 or 1 (Appendix B)

11. Life expectancy ≥ 12 weeks

12. Acceptable laboratory parameters:

13. Absolute neutrophil count > 1.0 x 109/L

14. Platelets > 75 x 109/L

15. Hemoglobin ≥ 9.0 g/dL

16. Creatinine ≤ 1.5 x ULN; or Measured creatinine clearance (CL) >40 mL/min; or
   Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault

17. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). This will not apply to subjects
   with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is
   predominantly unconjugated in the absence of evidence of hemolysis or hepatic
   pathology) who will be allowed in consultation with their physician.

18. AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)

19. Ability to understand and the willingness to sign the written IRB approved informed
   consent document.

20. Women of childbearing potential or their male partner must agree to use a highly
   effective method of contraception from enrollment until 8 months after final study
   therapy. (see section 4.6.1)

21. Body weight >30kg

Exclusion Criteria

   1. Involvement in the planning and/or conduct of the study

   2. 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.

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

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

   Exceptions: intranasal, inhaled, or topical corticosteroids or systemic
   corticosteroids at physiological doses, not to exceed 10 mg/day of prednisone

   5. Any unresolved toxicity CTCAE > Grade 2 from prior therapy with the exception of
   alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

      - Subjects with Grade > 2 neuropathy will be evaluated on a case by case basis
      after consultation with the Protocol Director / Principal Investigator

      - Subjects with irreversible toxicity that is not reasonably expected to be
      exacerbated by treatment with durvalumab may be included (ie, hearing loss) with
      permission from the Protocol Director / Co-Director.

   6. Active or prior documented autoimmune or inflammatory disorders which could limit the
   subjects ability to receive durvalumab on the study (including inflammatory bowel
   disease [eg, colitis or Crohn's disease], 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 may be taken in to considerations as
   exceptions to this criterion:

      1. Vitiligo or alopecia

      2. Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement

      3. Chronic skin condition not requiring systemic therapy

      4. Those without active disease in the last 5 years may be included with permission
      from the Protocol Director / Co-Director.

      5. Celiac disease controlled by diet alone

   7. History of primary immunodeficiency

   8. History of organ transplant requiring therapeutic immunosuppression

   9. Active infection including:

      - Grade 3 or higher clinically significant infection

      - Active known Hepatitis B [known positive results for HBV surface antigen (HBsAg)
      within 2 months prior to enrollment]. EXCEPTION: Subjects with a past or resolved
      HBV infection, defined as the presence of hepatitis B core antibody (anti HBc)
      and absence of HBsAg are eligible.

      - Active known Hepatitis C (HCV) EXCEPTION: Subjects positive for HCV antibody are
      eligible only if polymerase chain reaction is negative for HCV RNA

      - Active known tuberculosis infection (clinical evaluation that may include
      clinical history, physical examination and radiographic findings, or tuberculosis
      testing in line with local practice).

      - Active known HIV: tested positive for human immunodeficiency virus (HIV)
      (positive HIV 1/2 antibodies)

10. Receipt of live (growth/replication competent) attenuated vaccine within 30 days prior
   to enrollment.

   Note: Subjects, if enrolled, should not receive live vaccine while receiving the
   investigational product (IP), and through 30 days after the last dose of IP.

11. Uncontrolled intercurrent illness, including but not limited to clinically

      - Symptomatic congestive heart failure

      - Uncontrolled hypertension

      - Unstable angina pectoris

      - Cardiac arrhythmia

      - Interstitial lung disease (presence of radiation pneumonitis on CT scan is

      - Serious chronic gastrointestinal conditions associated with diarrhea

      - Psychiatric illness/social situations that would limit compliance with study
      requirement, substantially increase risk of incurring AEs or compromise the
      ability of the subject to give written informed consent.

12. Female subjects who are pregnant or breast feeding.

13. Any other medical condition that, in the investigator's opinion, makes the subject
   unsuitable for enrollment and study procedures.

14. Female subjects who are pregnant or breast-feeding; or subjects of reproductive
   potential of any gender who are not employing or who do not agree to employ an
   effective method of birth control (see Section 4.7) prior to trial enrollment.


device: AVENIO ctDNA Surveillance Kit

drug: Durvalumab


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Hwang

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