Small Cell Lung Cancer (SCLC)Phase 2NCT07149363
Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
A Phase 2 study testing Durvalumab 50 MG/ML in people with Small Cell Lung Cancer (SCLC), run by Alliance Foundation Trials, LLC. at 6 sites in United States.
Trial summary
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer (SCLC)
- What is being tested?
- Durvalumab 50 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Feb 2026to Feb 2031
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Body weight >30 kg.
- Must have a life expectancy of at least 12 weeks.
- Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
- Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
- Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
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- No prior systemic therapies, for small cell lung cancer.
- Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
- ECOG performance status 0-1.
Who cannot join
- Patients who are receiving any other investigational agents.
- Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
- Prior treatment with durvalumab.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
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- Superficial bladder cancer without active disease after treatment.
- Low grade prostate cancer without indication for active treatment.
- Adequately treated carcinoma in situ without evidence of disease.
- Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
- Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
- Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Quality Management and Compliance contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Michael Lanuti, MD, 617-726-3498, mlanuti@mgh.harvard.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22908
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
- Recruiting
Maine Medical Center
Scarborough, Maine, 04074
- Recruiting
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63108
About this study
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Read the detailed description
This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).
- Conditions
- Small Cell Lung Cancer (SCLC)
- Being tested
- Durvalumab 50 MG/ML
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab 50 MG/MLDrug
Also called Imfinzi®, MEDI4736
Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks).
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide | Experimental | 65 participants will be enrolled. Receives: Drug: Durvalumab 50 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery.
Measured: 2 years
Secondary outcomes (3)
Overall survival (OS)
To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved overall survival (OS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. OS is measured in months from the time of surgery.
Measured: 3 years
Safety of the regimen
The frequency of grade 3+ treatment-related adverse events will be reported.
Measured: 1 year
Safety of the regimen
The frequency of grade 3+ all-cause adverse events will be reported.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start12 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung Cancer (SCLC)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Chi-Fu Jeffrey Yang, MD, Study chair, Massachusetts General HospitalJacob Sands, MD, Study chair, Dana-Farber Cancer InstituteEvanthia Galanis, MD, Principal investigator, Alliance Foundation Trials, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149363
- Sponsor's protocol ID
- AFT-61
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07149363
- Acronym / sponsor ID
- AFT-61
- Conditions
- Small Cell Lung Cancer (SCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Alliance Foundation Trials, LLC.University, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 2 Sep 2025 (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.
This is a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
Detailed description
This is a phase II open-label, single-arm, multi-center study to evaluate the efficacy and safety of adjuvant immunotherapy with chemotherapy for completely resected pathologic T1-T2, N0-N1, M0 small cell lung cancer (SCLC). The statistical design includes a predefined range of alpha and power to detect an improvement in 2-year disease free survival (DFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide | Experimental | Drug: Durvalumab 50 MG/ML65 participants will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Body weight >30 kg.
- Must have a life expectancy of at least 12 weeks.
- Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
- Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
Key exclusion criteria (12 listed)
- Patients who are receiving any other investigational agents.
- Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
- Prior treatment with durvalumab.
- History of another primary malignancy except for:
- Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
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 |
|---|---|---|
| Durvalumab 50 MG/MLAlso: Imfinzi®, MEDI4736Following surgical removal of their small-cell lung cancer, participants will receive a combination of 1500 mg durvalumab and cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1, and etoposide 100 mg/m2 on days 1, 2, and 3, every 3 weeks for 4 cycles (a total of 12 weeks). Following the combination of chemotherapy and immunotherapy, participants will then receive 1500 mg durvalumab every 4 weeks for 9 cycles (a total of 36 weeks). | Drug | Durvalumab and one of the two chemotherapy combinations: cisplatin or carboplatin, and etoposide |
Primary outcome
Disease free survival (DFS)
Time frame: 2 years
To determine whether the addition of durvalumab to adjuvant chemotherapy after surgery for limited-stage SCLC leads to improved disease free survival (DFS) when compared to historical data of participants who received adjuvant chemotherapy without immunotherapy after surgery for SCLC. DFS is measured in months from the time of surgery.
3 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Safety of the regimen
Time frame: 1 year
Safety of the regimen
Time frame: 5 years
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 15 Oct 2026.
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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.
Quality Management and Compliance contact
Chi-Fu Jeffrey Yang, MD study chair
Massachusetts General Hospital
Jacob Sands, MD study chair
Dana-Farber Cancer Institute
Evanthia Galanis, MD principal investigator
Alliance Foundation Trials, LLC.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab 50 MG/ML in people with Small Cell Lung Cancer (SCLC), run by Alliance Foundation Trials, LLC. at 6 sites 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 9 inclusion and 12 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 15 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 6 sites 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 Quality Management and Compliance (617-732-8727, ClinicalTrials.Queries@alliancefoundationtrials.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.