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Non Small Cell Lung CancerPhase 3NCT04585490

Adaptive ctDNA-Based Personalization of Treatment During Consolidation Therapy in NSCLC

A Phase 3 study testing Durvalumab, Carboplatin and Pemetrexed in people with Non Small Cell Lung Cancer and NSCLC, Stage III, 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

The purpose of this study is to test whether or not number of circulating cancer cells detected in the blood can be decreased the by combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Durvalumab, Carboplatin and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
25 Aug 2021to Apr 2028
Phase
Phase 3
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically- or cytologically-documented NSCLC presenting with locally-advanced, unresectable stage III disease (Version 8 of AJCC Staging Manual) or NSCLC with locoregional recurrence after previous definitive treatment.
  • For stage III or recurrent disease, must have completed platinum-based chemotherapy and radiation therapy to all known tumor sites (60 Gy +/- 10%). Must not have known progression of disease.
  • Must be receiving consolidation durvalumab following completion of radiation and chemotherapy, and less than 32 weeks has elapsed from their first dose of durvalumab. (Patients may sign consent for study before start of durvalumab, but confirm eligibility and enroll only after first dose of durvalumab is received).
  • Able to potentially receive further consolidation chemotherapy plus durvalumab and tremelimumab, but not be currently intended to receive additional systemic consolidation chemotherapy apart from this durvalumab.
  • Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis
  • Aged 18 years or older
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  • Weight > 30kg
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Absolute neutrophil count > 1.0 x 109/L (1000/mm3)
  • Platelets > 75 x 109/L (100,000/mm3)
  • Hemoglobin ≥ 9.0 g/dL (5.59 mmol/L)
  • Measured creatinine clearance > 40 mL/min, by either 24 hour urine collection or the Cockcroft Gault formula
  • Males:
  • Mass(kg) x (140-Age) / 72 x serum creatinine (mg/dL)
  • Females:
  • Mass(kg) x (140-Age) x 0.85 / 72 x serum creatinine (mg/dL)
  • 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.
  • aspartate aminotransferase (AST) (SGOT)/Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 5 x ULN
  • Ability to understand and the willingness to sign the written IRB approved informed consent document.

Who cannot join

  • Involvement in the planning and/or conduct of the study
  • 2. Previous enrollment or randomization in the present study
  • 3. Received Investigational product as part of another clinical study
  • 4. Mixed small cell and non small cell lung cancer histology
  • 5. History of another primary malignancy and currently undergoing active treatment.
  • Exception: May participate if receiving adjuvant endocrine therapy for breast or prostate cancer.
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  • 6. Current or prior use of immunosuppressive medication within 14 days before enrollment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
  • 7. Any unresolved toxicity CTCAE > Grade 2 from the prior chemoradiation 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) only after consultation with the Protocol Director / Principal Investigator.
  • 8. Any prior Grade ≥ 3 immune related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1) that may limit subject from continuing durvalumab during the study
  • 9. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of study drug.
  • 10. Active or prior documented autoimmune or inflammatory disorders which is likely to limit the subjects ability to continue 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]). Those with history of autoimmune or inflammatory disorders who are currently tolerating durvalumab may be eligible to participate with approval from the PI. The following are also exceptions to this criterion:
  • Vitiligo or alopecia
  • Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
  • Chronic skin condition not requiring systemic therapy
  • Celiac disease controlled by diet alone
  • 11. History of primary immunodeficiency
  • 12. History of organ transplant requiring therapeutic immunosuppression
  • 13. History of hypersensitivity to carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel that is likely to prevent re-administration of these agents
  • 14. Active infection including but not limited to:
  • 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 infection
  • 15. Receipt of live attenuated vaccine within 30 days prior to the first dose of concurrent chemotherapy and durvalumab. Note: Subjects, if enrolled, should not receive live vaccine through 30 days after the last dose of chemotherapy concurrent with durvalumab.
  • 16. Uncontrolled intercurrent illness, including but not limited to:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Uncontrolled hypertension
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Interstitial lung disease
  • 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.
  • 17. 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 prior to trial enrollment.ollment.

Trial locations and contacts

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

Rene Bonilla contact

650-498-7703

rbonilla@stanford.edu

United States1 site, 1 recruiting

  • Stanford University

    Stanford, California, 94304

    Rene NH Bonilla, 650-498-7703, rbonilla@stanford.edu

    Maximilian Diehn, MD

    Recruiting

Other trials in United States

About this study

Official title: ADAPT-C: Adaptive ctDNA-Based Personalization of Treatment During Consolidation Therapy in NSCLC

The purpose of this study is to test whether or not number of circulating cancer cells detected in the blood can be decreased the by combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy

Read the detailed description

Primary objective is to measure the change in the levels of circulating tumor DNA (ctDNA) in Cohort 1 (MRD+) due to the addition of Tremelimumab and platinum doublet chemotherapy in subjects with stage III unresectable disease with positive DNA treated with consolidation chemotherapy and immunotherapy.

Secondary Objectives:

To determine the proportion of subjects in Cohort 1 MRD+ for whom ctDNA becomes undetectable after adding chemotherapy and tremelimumab to consolidation durvalumab

To describe compare overall survival (OS) of subjects with baseline detectable ctDNA (Cohort 1 MRD+) vs baseline undetectable ctDNA (Cohort 2 MRD ) ·To compare progression free survival (PFS) between subjects with baseline detectable (Cohort 1 MRD+) vs baseline undetectable ctDNA (Cohort 2 MRD )

Keywords
durvalumab, tremelimumab
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.

  • DurvalumabDrug

    Also called Imfinzi, MEDI-4736, MEDI4736

    Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)

  • CarboplatinDrug

    Also called Carboplat, Carbosol, Carboplatino, cis-diammine(cyclobutane-1,1-dicarboxylato)platinum

    Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle

  • PemetrexedDrug

    Also called Alimta, MTA, LY231514, L-glutamic acid, N-(4-(2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)

    500mg/m2 on Day 1 of every 21-day cycle

  • PaclitaxelDrug

    Also called Praxel

    175mg/m2 on Day 1 of every 21-day cycle

  • CisplatinDrug

    Also called platinum diamminodichloride, Abiplatin, Cismaplat, cis-platinum

    Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin

  • AVENIO ctDNA Surveillance KitDevice

    Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)

  • TremelimumabDrug

    Also called Imjudo, Tremelimumab-actl, Ticilimumab, CP-675

    not to exceed 75mg IV on Day 1 of every 21-day cycle

Study groups in NCT04585490
Study groupRoleWhat they receive
Cohort 1 minimal residual disease positive (MRD+)ExperimentalSubjects with detectable ctDNA will receive 4 cycles of platinum doublet chemotherapy [carboplatin/pemetrexed], tremelimumab (75 mg IV every 21 days) and durvalumab (1500 mg IV every 21 days), except subjects with squamous cell carcinoma histology will receive carboplatin/paclitaxel. Subjects will be evaluated with PET/CT and/or computed tomography (CT) thorax every 12 weeks. Following ctDNA evaluation, in the absence of progression or toxicity, subject will continue with durvalumab to complete 1 year of treatment as standard of care.
Receives: Drug: Durvalumab; Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Cisplatin; Device: AVENIO ctDNA Surveillance Kit; Drug: Tremelimumab
Cohort 2 minimal residual disease negative (MRD )ExperimentalSubjects with undetectable ctDNA at study enrollment will receive standard of care durvalumab (10 mg/kg every 2 weeks, or equivalent, for 1 year). If subjects in Cohort 2 MRD progress prior to close of study, blood will be drawn for ctDNA testing.
Receives: Drug: Durvalumab; Device: AVENIO ctDNA Surveillance Kit

What is being measured

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

  1. Change in ctDNA Level Following Chemotherapy

    Participants in Cohort 1 MRD+ will be assessed for ctDNA levels at baseline and end of treatment, expected to be 4 cycles of 3 weeks per cycle (defined as ctDNA evaluable set or ctDES). The outcome will be assessed as the number of participants with a ≥ 3 fold decrease in ctDNA level, a number without dispersion.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Presence of Detectable ctDNA Following Chemotherapy

    Participants in Cohort 1 MRD+ will be assessed for ctDNA levels at baseline and end of treatment, expected to be 4 cycles of 3 weeks per cycle. The outcome will be assessed as the number of participants with or without detectable ctDNA, a number without dispersion.

    Measured: 12 weeks

  2. Overall Survival (OS)

    Overall survival (OS) is defined as the period a participant remains alive after study registration until death due to any cause. Participants lost to follow up will be censored at last known date alive. The outcome will be reported as the number of participants in both cohorts remaining alive after 2 years, a number without dispersion.

    Measured: 2 years

  3. Progression free survival (PFS)

    Progression free survival (PFS) is defined as the period a participant remains alive without disease progression after study registration. Tumor status is assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) by computed tomography (CT), positron emission tomography (PET) CT; and/or X rays. Participants lost to follow up will be censored at last known date alive. The outcome will be reported as the number of participants in both cohorts remaining alive without progression after 2 years, a number without dispersion.

    • Complete Response (CR) = Disappearance of all lesions
    • Partial Response (PR) = ≥30% decrease in the sum of the lesion diameters
    • Overall Response (OR) = CR + PR
    • Progressive disease (PD) = 20% increase in the sum of lesion diameters, and/or the appearance of 1+ new lesion(s)
    • Stable disease (SD) = Small changes that do not meet any of the above criteria

    Measured: 2 years

  4. Durvalumab and Tremelimumab related Adverse Events (Cohort 1 MRD+ only)

    Adverse events will be collected for participants of Cohort 1 (MRD+) who initiate treatment with durvalumab and tremelimumab through 930 days after the last dose of durvalumab. AE grade per the Common Terminology Criteria for Adverse Events (CTCAE v5) criteria and relationship to study treatment will be assessed. The outcome will be reported as the number of durvalumab and tremelimumab related adverse events by grade that Cohort 1 MRD+ participants experienced.

    Measured: 13 months

Timeline

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

  1. First posted14 Oct 2020
  2. Study start25 Aug 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585490
Sponsor's protocol ID
IRB-54807
Other IDs
LUN0114, NCI-2021-09500
Status last verified
Sep 2026
First submitted
6 Oct 2020
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab, Carboplatin and Pemetrexed in people with Non Small Cell Lung Cancer and NSCLC, Stage III, run by Stanford University at 1 site in United States.

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 20 inclusion and 37 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 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Rene Bonilla (650-498-7703, rbonilla@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in ctDNA Level Following Chemotherapy (time frame: 12 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 NCT04585490.

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 Sep 2026.

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