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Extensive Stage-Small Cell Lung Cancer (ES-SCLC)Phase 2NCT07895043

A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) ABBV-706 in Combination With Alveltamig and Atezolizumab for Adults Participants With Extensive Stage-Small Cell Lung Cancer

A Phase 2 study testing Alveltamig, Atezolizumab and ABBV-706 in people with Extensive Stage-Small Cell Lung Cancer (ES-SCLC), run by AbbVie.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Small cell lung cancer (SCLC) is a type of lung cancer that accounts for approximately 15-17% of all lung cancers. It is characterized by aggressive and rapid growth and early spread to distant sites. Extensive stage-small cell lung cancer (ES-SCLC) includes cases where disease has spread beyond one side of the chest. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alveltamig, Atezolizumab and ABBV-706
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
20 Nov 2026to Dec 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

  • Diagnosis of histologically or cytologically confirmed extensive stage-small cell lung cancer (ES-SCLC) requiring treatment with first-line therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Must have measurable disease per RECIST v1.1
  • Has an archival or recent diagnostic FFPE tumor specimen collected no more than 6 months prior to Cycle 1 Day 1
  • No clinically significant conditions that would adversely affect the participation in the study, and the subject should have a life expectancy of at least 3 months.

Who cannot join

  • Prior systemic therapy for the treatment of limited stage-SCLC and/or first-line ES-SCLC
  • Prior treatment with topoisomerase 1 inhibitors, including belotecan, camptothecin, exatecan, irinotecan, rubitecan and topotecan, and any ADC that consists of a Top1i payload.
  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest CT scan

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

About this study

Official title: A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of ABBV-706 in Combination With Alveltamig and Atezolizumab in First-Line in Subjects With Extensive Stage-Small Cell Lung Cancer (ES-SCLC)

Small cell lung cancer (SCLC) is a type of lung cancer that accounts for approximately 15-17% of all lung cancers. It is characterized by aggressive and rapid growth and early spread to distant sites. Extensive stage-small cell lung cancer (ES-SCLC) includes cases where disease has spread beyond one side of the chest. This study will evaluate the safety and efficacy of ABBV-706 in combination with atezolizumab and alveltamig in previously untreated ES-SCLC.

ABBV-706 and alveltamig are investigational drugs being developed for the treatment of ES-SCLC. This is an open-label study, meaning participants and doctors know which treatment is being given. Participants are placed into 1 of 2 treatment arms. Each arm receives a different dose of ABBV-706 in combination with alveltamig and atezolizumab. Adult participants with a diagnosis of previously untreated extensive stage-small cell lung cancer will be enrolled. Around 80 participants will be enrolled in the study at approximately 25 sites worldwide.

Read more

Participants will receive intravenous (IV) infusion of ABBV-706 in combination with IV infusion of atezolizumab and IV infusion of alveltamig. The estimated duration of the study is approximately 61 months.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, imaging scans, checking for side effects and completing questionnaires.

Being tested
Alveltamig, Atezolizumab, ABBV-706
Keywords
Extensive Stage-Small Cell Lung Cancer, ABBV-706, Alveltamig, Atezolizumab, Cancer
Medical subject headings
Neoplasms

What participants receive

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

  • AlveltamigDrug

    Intravenous

  • AtezolizumabDrug

    Intravenous

  • ABBV-706Drug

    Intravenous

Study groups in NCT07895043
Study groupRoleWhat they receive
ABBV-706 Dose A + Alveltamig + AtezolizumabExperimentalParticipants will receive ABBV-706 dose A in combination with alveltamig and atezolizumab during the safety lead-in and dose expansion periods.
Receives: Drug: Alveltamig; Drug: Atezolizumab; Drug: ABBV-706
ABBV-706 Dose B + Alveltamig + AtezolizumabExperimentalParticipants will receive ABBV-706 dose B in combination with alveltamig and atezolizumab during the safety lead-in and dose expansion periods.
Receives: Drug: Alveltamig; Drug: Atezolizumab; Drug: ABBV-706

What is being measured

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

  1. Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Objective response (OR) is defined as best overall response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by Blinded Independent Central Review (BICR) per RECIST v1.1 prior to subsequent anti-cancer therapy.

    Measured: Up to approximately 4 years

  2. Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 4 years

Secondary outcomes (6)

  1. Progression-Free Survival (PFS) as Assessed by BICR Per RECIST v1.1

    PFS is defined as the time from the date of randomization to the first documentation of radiographic disease progression per RECIST v1.1 based on BICR assessment or death from any cause, whichever occurs first.

    Measured: Up to approximately 3.5years

  2. Disease Control Rate (DCR) as Assessed by BICR

    DCR is defined as achieving an objective response (OR) or stable disease (SD) at any time prior to subsequent anti-cancer therapy, as assessed by BICR

    Measured: Up to approximately 4 years

  3. Duration of Response (DoR) as Assessed by BICR

    DoR is defined as time from the initial response of complete response (CR) or partial response (PR) until the first documentation of radiographic progressive disease (PD) or death from any cause, whichever occurs first, as assessed by BICR

    Measured: Up to approximately 4 years

  4. Overall Survival

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to approximately 3.5 years

  5. Percentage of Participants Achieving Molecular Response (≥50% Reduction)

    Molecular response is defined as a ≥50% reduction in tumor fraction (TF) as measured by methylation-based circulating tumor DNA (ctDNA) assay (Guardant Reveal on the Infinity platform).

    Measured: Up to approximately 6 weeks

  6. Percentage of Participants Achieving Complete Molecular Clearance (100% Reduction)

    Complete molecular clearance is defined as 100% reduction in tumor fraction (TF), meaning TF becomes unquantifiable (below the limit of quantification [LOQ] of <0.01% TF) from baseline (Cycle 1 Day 1) to Cycle 3 Day 1 as measured by methylation-based circulating tumor DNA (ctDNA) assay (Guardant Reveal on the Infinity platform).

    Measured: Up to approximately 6weeks

Timeline

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

  1. First posted26 Oct 2026
  2. Study start20 Nov 2026 (estimated)
  3. Primary completionDec 2031 (estimated)
  4. Study completionDec 2031 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895043
Sponsor's protocol ID
M26-387
Other IDs
2026-526833-25-00
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alveltamig, Atezolizumab and ABBV-706 in people with Extensive Stage-Small Cell Lung Cancer (ES-SCLC), run by AbbVie.

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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) (time frame: Up to approximately 4 years). The study lists 2 primary outcomes in all. 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 NCT07895043.

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 26 Oct 2026.

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