Extensive Stage-Small Cell Lung CancerPhase 2NCT07895056
A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) ABBV-706 in Combination With Tarlatamab and Atezolizumab in Adult Participants With Extensive Stage-Small Cell Lung Cancer
A Phase 2 study testing ABBV-706, Tarlatamab and Atezolizumab in people with Extensive Stage-Small Cell Lung Cancer, run by AbbVie.
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
- Conditions the study is for
- Extensive Stage-Small Cell Lung Cancer
- What is being tested?
- ABBV-706, Tarlatamab and Atezolizumab
- 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
- 4 Nov 2026to Aug 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 Response Evaluation Criteria in Solid Tumors (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 firstline extensive stage-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 or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease/pneumonitis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of ABBV-706 in Combination With Tarlatamab and Atezolizumab in First-Line 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. The purpose of this study is to assess safety and efficacy of ABBV-706 in combination with tarlatamab and atezolizumab in participants with ES-SCLC.
ABBV-706 is an investigational drug being developed for the treatment of ESSCLC. 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 tarlatamab and atezolizumab. Adult participants with a diagnosis of 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) doses of ABBV-706 in combination with IV atezolizumab and IV tarlatamab. The study will run for a duration of approximately 62 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.
- Conditions
- Extensive Stage-Small Cell Lung Cancer
- Being tested
- ABBV-706, Tarlatamab, Atezolizumab
- Keywords
- Extensive Stage-Small Cell Lung Cancer, ES-SCLC, ABBV-706, Tarlatamab, 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.
ABBV-706Drug
Intravenous
TarlatamabDrug
Intravenous
AtezolizumabDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| ABBV-706 Dose A + Tarlatamab + Atezolizumab | Experimental | Participants will receive ABBV-706 dose A in combination with atezolizumab and tarlatamab during the safety lead-in and dose expansion periods. Receives: Drug: ABBV-706; Drug: Tarlatamab; Drug: Atezolizumab |
| ABBV-706 Dose B + Tarlatamab + Atezolizumab | Experimental | Participants will receive ABBV-706 dose B in combination with atezolizumab and tarlatamab during the safety lead-in and dose expansion periods. Receives: Drug: ABBV-706; Drug: Tarlatamab; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (OR) measured by overall response rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1.
Measured: Up to Approximately 4 Years
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 (4)
Duration of Response (DoR) Based on BICR Per RECIST v1.1
DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.
Measured: Up to Approximately 4 Years
Disease Control (DC) Based on BICR Per RECIST v1.1
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1
Measured: Up to Approximately 4 Years
Overall Survival (OS)
OS is defined as the time from date of randomization to the event of death from any cause.
Measured: Up to Approximately 3.5 Years
Progression-Free Survival (PFS) Based on BICR Per RECIST v1.1
PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.
Measured: Up to Approximately 3.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start4 Nov 2026 (estimated)
- Primary completionAug 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895056
- Sponsor's protocol ID
- M26-386
- Other IDs
- 2026-525845-58
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of ABBV-706 in Combination With Tarlatamab and Atezolizumab in First-Line Extensive Stage-Small Cell Lung Cancer (ES-SCLC)
- ClinicalTrials.gov ID
- NCT07895056
- Acronym / sponsor ID
- M26-386
- Conditions
- Extensive Stage-Small Cell Lung Cancer
- Keywords
- Extensive Stage-Small Cell Lung Cancer, ES-SCLC, ABBV-706, Tarlatamab, Atezolizumab, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- Aug 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 26 Oct 2026 (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.
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. The purpose of this study is to assess safety and efficacy of ABBV-706 in combination with tarlatamab and atezolizumab in participants with ES-SCLC.
ABBV-706 is an investigational drug being developed for the treatment of ESSCLC. 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 tarlatamab and atezolizumab. Adult participants with a diagnosis of 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) doses of ABBV-706 in combination with IV atezolizumab and IV tarlatamab. The study will run for a duration of approximately 62 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBV-706 Dose A + Tarlatamab + Atezolizumab | Experimental | Drug: ABBV-706, Drug: Tarlatamab, Drug: AtezolizumabParticipants will receive ABBV-706 dose A in combination with atezolizumab and tarlatamab during the safety lead-in and dose expansion periods. |
| ABBV-706 Dose B + Tarlatamab + Atezolizumab | Experimental | Drug: ABBV-706, Drug: Tarlatamab, Drug: AtezolizumabParticipants will receive ABBV-706 dose B in combination with atezolizumab and tarlatamab during the safety lead-in and dose expansion periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 Response Evaluation Criteria in Solid Tumors (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.
Key exclusion criteria (3 listed)
- Prior systemic therapy for the treatment of limited stage-SCLC and/or firstline extensive stage-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 or pneumonitis that required treatment with systemic steroids, or any evidence of active interstitial lung disease/pneumonitis
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 |
|---|---|---|
| ABBV-706Intravenous | Drug | ABBV-706 Dose A + Tarlatamab + Atezolizumab, ABBV-706 Dose B + Tarlatamab + Atezolizumab |
| TarlatamabIntravenous | Drug | ABBV-706 Dose A + Tarlatamab + Atezolizumab, ABBV-706 Dose B + Tarlatamab + Atezolizumab |
| AtezolizumabIntravenous | Drug | ABBV-706 Dose A + Tarlatamab + Atezolizumab, ABBV-706 Dose B + Tarlatamab + Atezolizumab |
Primary outcome
Objective Response (OR) measured by overall response rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Up to Approximately 4 Years
OR is defined as participants achieving a best overall response of confirmed complete response (CR) or partial response (PR) per BICR based on RECIST version 1.1.
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately 4 Years
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.
4 secondary outcomes
Duration of Response (DoR) Based on BICR Per RECIST v1.1
Time frame: Up to Approximately 4 Years
Disease Control (DC) Based on BICR Per RECIST v1.1
Time frame: Up to Approximately 4 Years
Overall Survival (OS)
Time frame: Up to Approximately 3.5 Years
Progression-Free Survival (PFS) Based on BICR Per RECIST v1.1
Time frame: Up to Approximately 3.5 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 26 Oct 2026.
- Individual participant dataSharing planned: 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.
Related trials for Extensive Stage-Small Cell Lung Cancer
Active, not recruitingPhase 3
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
Extensive-Stage Small-Cell Lung Cancer, Small-Cell Lung Cancer
RecruitingPhase 2
A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC
Extensive-stage Small-cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
RecruitingPhase 2
MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer
Small Cell Lung Cancer, SCLC
Not yet recruitingPhase 2
Low-Dose Radiotherapy Plus Adebrelimab and Chemotherapy for Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC), SCLC, Extensive Stage
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.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABBV-706, Tarlatamab and Atezolizumab in people with Extensive Stage-Small Cell Lung Cancer, 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) measured by overall response rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (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?
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.