Non-small Cell Lung CancerPhase 2NCT04585477

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

A Phase 2 study testing AVENIO ctDNA Surveillance Kit, Durvalumab and Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy in people with Non-small Cell Lung Cancer and Non-small Cell Lung Cancer Stage I, run by Stanford University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II
What is being tested?: AVENIO ctDNA Surveillance Kit, Durvalumab and Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 8 Apr 2021to 30 Dec 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.
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)

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Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis
Not received immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies) or be intended to receive immunotherapy, apart from this study.
Not received another systemic anti-cancer investigational product during the 4 weeks prior to enrollment.
Aged 18 years or older
ECOG Performance Status of 0 or 1 (Appendix B)
Life expectancy ≥ 12 weeks
Acceptable laboratory parameters:
Absolute neutrophil count > 1.0 x 109/L
Platelets > 75 x 109/L
Hemoglobin ≥ 9.0 g/dL
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 1976)
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.
AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
Ability to understand and the willingness to sign the written IRB approved informed consent document.
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)
Body weight >30kg

Who cannot join

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.
Exceptions: intranasal, inhaled, or topical corticosteroids or systemic corticosteroids at physiological doses, not to exceed 10 mg/day of prednisone equivalent
Any unresolved toxicity CTCAE > Grade 2 from prior therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

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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.
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:
Vitiligo or alopecia
Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
Chronic skin condition not requiring systemic therapy
Those without active disease in the last 5 years may be included with permission from the Protocol Director / Co-Director.
Celiac disease controlled by diet alone
History of primary immunodeficiency
History of organ transplant requiring therapeutic immunosuppression
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)
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.
Uncontrolled intercurrent illness, including but not limited to clinically significant:
Symptomatic congestive heart failure
Uncontrolled hypertension
Unstable angina pectoris
Cardiac arrhythmia
Interstitial lung disease (presence of radiation pneumonitis on CT scan is allowed)
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.
Female subjects who are pregnant or breast feeding.
Any other medical condition that, in the investigator's opinion, makes the subject unsuitable for enrollment and study procedures.
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Lundi, BS contact

650 723-1002

llundi@stanford.edu

United States1 site, 1 recruiting

Stanford University
Stanford, California, 94305
Laura Lundi, 650-723-1002, llundi@stanford.edu
Joel W Neal, MD, PhD
Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Primary Objective:

The primary objective of this study is to measure the change in ctDNA from trial enrollment to after 2 cycles of adjuvant durvalumab in subjects with stage I to III NSCLC who had positive ctDNA following definitive treatment with surgery or radiation and completion of adjuvant standard of care chemotherapy. Secondary Objectives

To compare disease free survival (DFS)
To compare overall survival (OS)
To evaluate the frequency and severity of toxicity
To evaluate the severity of toxicity

Conditions: Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III
Being tested: AVENIO ctDNA Surveillance Kit, Durvalumab, Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AVENIO ctDNA Surveillance KitDevice
Also called The AVENIO ctDNA Surveillance Kit
Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
DurvalumabDrug
Also called IMFINZI, MEDI4736
Participants in the intervention arm will receive Durvalumab (1500 mg IV every 4 weeks for up to 12 months) as monotherapy or 20mg/kg if weight is 30kg or less.
Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapyDrug
Participants in the intervention arm (Cohort 1 MRD+) will receive a fixed dose of Durvalumab (1500 mg IV every 4 weeks for up to 12 months), either as monotherapy or in combination with a platinum-based chemotherapy regimen (investigator's choice). Platinum-based chemotherapy options include carboplatin, cisplatin, pemetrexed, paclitaxel, or nab-paclitaxel, administered per standard of care for up to 4 cycles.

Study groups in NCT04585477
Study group	Role	What they receive
Cohort 1 minimal residue disease positive(MRD+)	Experimental	Subjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles). Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS). Receives: Device: AVENIO ctDNA Surveillance Kit; Drug: Durvalumab; Drug: Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy
Cohort 2 minimal residue disease negative (MRD-)	Active comparator	Subjects with undetectable ctDNA (MRD) will receive Standard of care and no treatment Receives: Device: AVENIO ctDNA Surveillance Kit; Drug: Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Decrease in ctDNA Level
Change in minimal residual disease (MRD) will be assessed on the basis of reduction of circulating tumor DNA (ctDNA) in the blood of participants in Cohort 1 MRD+ only. ctDNA is an indicator of MRD. The outcome will be reported as the number of participants who have a ≥ 3-fold drop in ctDNA levels after 2 cycles of durvalumab treatment, a number without dispersion.
Measured: 8 weeks

Secondary outcomes (4)

Presence or absence of detectable ctDNA
Circulating tumor DNA (ctDNA) in the blood is an indicator of minimal residual disease (MRD), a risk factor for future relapse or progression. The outcome will be reported as the number of Cohort 1 MRD+ participants for whom, following 2 cycles of durvalumab, ctDNA was detected, not detected, or unable to be determined, each a number without dispersion. Available data for Cohort 2 MRD- participants will also be reported for the 8-week timepoint.
Measured: 8 weeks
Overall survival (OS)
Overall survival (OS) defined as the duration from study registration until death due to any cause. The outcome will be reported as the number of participants in each cohort known to be alive at 12 months after study registration, a number without dispersion.
Measured: 12 months
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the number of participants remaining alive without disease progression (DP), symptomatic deterioration, or death due to any cause. DP is assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as follows.
- Complete Response (CR) = Disappearance of all target lesions
- Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions
- Progressive disease (PD) = 20% increase in the sum of the diameters of target lesions (must be > 5 mm), unequivocal progression of non-target lesions, and/or the appearance of one or more new lesion(s)
- Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome will be reported as the number of participants who meet the criteria for DFS, a number without dispersion.
Measured: 8 weeks
Related Adverse Events
Related adverse events (AEs) are deleterious events determined to be possibly, probably, or definitely-related to durvalumab treatment. The outcome will be reported as the number of related AEs experienced by the participants in Cohort 1 MRD+ only (ie, durvalumab treatment cohort), a number without dispersion.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202130 Dec 2027

First posted14 Oct 2020
Study start8 Apr 2021
Primary completion30 Dec 2027 (estimated)
Study completion30 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04585477
Sponsor's protocol ID: IRB-54622
Other IDs: LUN0115, NCI-2021-03445
Status last verified: Oct 2026
First submitted: 6 Oct 2020
Last updated: 30 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
ClinicalTrials.gov ID: NCT04585477
Acronym / sponsor ID: IRB-54622
Conditions: Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I, Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage III
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: AstraZeneca
Study start: 8 Apr 2021 (actual)
Primary completion: 30 Dec 2027 (estimated)
Study completion: 30 Dec 2027 (estimated)
First posted: 14 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary Objective:

To compare disease free survival (DFS)
To compare overall survival (OS)
To evaluate the frequency and severity of toxicity
To evaluate the severity of toxicity

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1 minimal residue disease positive(MRD+)	Experimental	Device: AVENIO ctDNA Surveillance Kit, Drug: Durvalumab, Drug: Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapySubjects with detectable ctDNA (MRD+) will receive up to 12 cycles of durvalumab (1500mg dose by intravenous (by vein) injection every 28 days). ctDNA will be re checked following 2 cycles (8 weeks) of durvalumab and compared to baseline levels. In the absence of progression or toxicity after 2 cycles, subject will continue with durvalumab to complete 1 year of treatment about 10 additional cycles). Subjects will be monitored for secondary endpoints of progression free survival (PFS) and overall survival (OS).
Cohort 2 minimal residue disease negative (MRD-)	Active comparator	Device: AVENIO ctDNA Surveillance Kit, Drug: Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapySubjects with undetectable ctDNA (MRD) will receive Standard of care and no treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

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.
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.

Key exclusion criteria (35 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AVENIO ctDNA Surveillance KitAlso: The AVENIO ctDNA Surveillance KitRoche Sequencing and Life Science kit to detect minimal residue disease (MRD)	Device	Cohort 1 minimal residue disease positive(MRD+), Cohort 2 minimal residue disease negative (MRD-)
DurvalumabAlso: IMFINZI, MEDI4736Participants in the intervention arm will receive Durvalumab (1500 mg IV every 4 weeks for up to 12 months) as monotherapy or 20mg/kg if weight is 30kg or less.	Drug	Cohort 1 minimal residue disease positive(MRD+)
Durvalumab (Imfinzi) alone or in combination with platinum-based chemotherapyParticipants in the intervention arm (Cohort 1 MRD+) will receive a fixed dose of Durvalumab (1500 mg IV every 4 weeks for up to 12 months), either as monotherapy or in combination with a platinum-based chemotherapy regimen (investigator's choice). Platinum-based chemotherapy options include carboplatin, cisplatin, pemetrexed, paclitaxel, or nab-paclitaxel, administered per standard of care for up to 4 cycles.	Drug	Cohort 1 minimal residue disease positive(MRD+), Cohort 2 minimal residue disease negative (MRD-)

Primary outcome

Decrease in ctDNA Level
Time frame: 8 weeks
Change in minimal residual disease (MRD) will be assessed on the basis of reduction of circulating tumor DNA (ctDNA) in the blood of participants in Cohort 1 MRD+ only. ctDNA is an indicator of MRD. The outcome will be reported as the number of participants who have a ≥ 3-fold drop in ctDNA levels after 2 cycles of durvalumab treatment, a number without dispersion.

4 secondary outcomes

Presence or absence of detectable ctDNA
Time frame: 8 weeks
Overall survival (OS)
Time frame: 12 months
Disease-free survival (DFS)
Time frame: 8 weeks
Related Adverse Events
Time frame: 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Laura Lundi, BS contact

650 723-1002

llundi@stanford.edu

Joel W Neal, MD,PhD principal investigator

Stanford Universiy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Lundi, BS (650 723-1002, llundi@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease in ctDNA Level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.