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Not yet recruitingNCT07895043Updated Oct 26, 2026

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 interventional study of Alveltamig and Atezolizumab in Extensive Stage-Small Cell Lung Cancer (ES-SCLC), sponsored by AbbVie. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Extensive Stage-Small Cell Lung Cancer (ES-SCLC)

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Keywords

  • Extensive Stage-Small Cell Lung Cancer
  • ABBV-706
  • Alveltamig
  • Atezolizumab
  • Cancer
03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

AbbVie is the lead sponsor of 969 studies on the registry; 134 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    ABBV-706 Dose A + Alveltamig + Atezolizumab

    Participants will receive ABBV-706 dose A in combination with alveltamig and atezolizumab during the safety lead-in and dose expansion periods.

    Drug: Alveltamig · Drug: Atezolizumab · Drug: ABBV-706

  • Experimental
    ABBV-706 Dose B + Alveltamig + Atezolizumab

    Participants will receive ABBV-706 dose B in combination with alveltamig and atezolizumab during the safety lead-in and dose expansion periods.

    Drug: Alveltamig · Drug: Atezolizumab · Drug: ABBV-706

Interventions

  • DrugAlveltamig

    Intravenous

  • Intravenous

  • DrugABBV-706

    Intravenous

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Up to approximately 4 years

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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

    Time frame: Up to approximately 4 years

  4. Overall Survival

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

    Time frame: 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).

    Time frame: 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).

    Time frame: Up to approximately 6weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Dec 2031, 61 months later.

Of 162 industry-sponsored phase 2 interventional studies under Neoplasms, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 72. This study's planned 61 months is above that.

Counting every sponsor, half of 554 studies reached it within 52 months; a quarter within 33 and three quarters within 88.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 26, 2026
StartEst.
Nov 20, 2026
Primary completionEst.
Dec 2031
CompletionEst.
Dec 2031
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895043
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Oct 26, 2026
Start date
Nov 20, 2026 (estimated)
Primary completion
Dec 2031 (estimated)
Completion
Dec 2031 (estimated)
Last update
Oct 26, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Atezolizumab

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