A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

New first-line treatment for extensive stage small cell lung cancer

NCT: NCT07155174 · Status: RECRUITING · Phase: Phase 2 · Sponsor: AbbVie · Started: 2025-11-25 · Est. Completion: 2031-09

Plain English Summary

A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer is a Phase 2 clinical trial sponsored by AbbVie studying Small Cell Lung Cancer. This trial tests a new drug combination (ABBV-706 with atezolizumab) against the current standard treatment for newly diagnosed extensive stage small cell lung cancer. It is for adults with extensive stage small cell lung cancer who have not received any prior treatment for this condition. Participants will receive one of two doses of the new drug combination or the standard treatment, and will have regular medical assessments, tests, and scans. Standard treatment options for this type of cancer include chemotherapy and immunotherapy. The trial aims to enroll 180 participants.

Official Summary

Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide. In the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have been diagnosed with extensive stage small cell lung cancer and need first-line treatment. You must have a good general health status (ECOG 0-1) and measurable disease. You cannot join if you have received prior treatment for small cell lung cancer, have active or symptomatic brain metastases, or have a history of lung inflammation requiring steroid treatment. Participants must be adults and have a life expectancy of at least 3 months. This trial is studying Small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the new treatment is by tracking side effects and how long patients live without their cancer getting worse. The specific primary outcome measures are: Number of Participants with Adverse Events (AE)s (Up to 69.5 Months); Progression-Free Survival (PFS) Based on Investigator Assessment (Up to Approximately 24 Months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to find a better first-line treatment for extensive stage small cell lung cancer, a very aggressive cancer with limited treatment options. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial is investigating a novel combination therapy for a difficult-to-treat cancer, potentially addressing a significant unmet need and representing a substantial market opportunity if successful Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of joining this trial, and how it compares to standard treatment. Be prepared for frequent visits to the hospital or clinic for assessments, tests, and scans. Understand that participation may involve a higher treatment burden than standard care. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.
* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
* Suspected brain metastases at screening should have a computed tomography (CT)/ magnetic resonance imaging (MRI) of the brain prior to study entry.

Exclusion Criteria:

* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).
* Known active/symptomatic central nervous system (CNS) metastases should be excluded.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan should be excluded.
* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07155174?

NCT07155174 is a Phase 2 INTERVENTIONAL study titled "A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer." It is currently recruiting and is sponsored by AbbVie. The trial targets enrollment of 180 participants.

What conditions does NCT07155174 study?

This trial investigates treatments for Small Cell Lung Cancer. The primary condition under study is Small Cell Lung Cancer.

What treatments are being tested in NCT07155174?

The interventions being studied include: ABBV-706 (DRUG), Atezolizumab (DRUG), Etoposide (DRUG), Carboplatin (DRUG), Carboplatin (DRUG). Intravenous (IV) Infusion

What does Phase 2 mean for NCT07155174?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT07155174?

This trial is currently "Recruiting." It started on 2025-11-25. The estimated completion date is 2031-09.

Who is sponsoring NCT07155174?

NCT07155174 is sponsored by AbbVie. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07155174?

The trial aims to enroll 180 participants. The trial is currently recruiting and accepting new participants.

How is NCT07155174 designed?

This is a interventional study, uses randomized allocation, follows a sequential design, employs none masking.

What are the primary outcomes being measured in NCT07155174?

The primary outcome measures are: Number of Participants with Adverse Events (AE)s (Up to 69.5 Months); Progression-Free Survival (PFS) Based on Investigator Assessment (Up to Approximately 24 Months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07155174 being conducted?

This trial is being conducted at 20 sites, including New Haven, Connecticut; Ocala, Florida; Tampa, Florida; Fort Wayne, Indiana and 16 more sites (United States, Belgium, Germany).

Where can I find official information about NCT07155174?

The official record for NCT07155174 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07155174. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07155174 testing in simple terms?

This trial tests a new drug combination (ABBV-706 with atezolizumab) against the current standard treatment for newly diagnosed extensive stage small cell lung cancer. It is for adults with extensive stage small cell lung cancer who have not received any prior treatment for this condition.

Why is this trial significant?

This trial aims to find a better first-line treatment for extensive stage small cell lung cancer, a very aggressive cancer with limited treatment options.

What are the potential risks of participating in NCT07155174?

Common side effects may include fatigue, nausea, diarrhea, and changes in blood counts. More serious risks can include severe allergic reactions, lung inflammation, and effects on the liver or kidneys. The new drug combination may have different or more intense side effects than standard treatment. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07155174?

Ask your doctor about the potential benefits and risks of joining this trial, and how it compares to standard treatment. Be prepared for frequent visits to the hospital or clinic for assessments, tests, and scans. Understand that participation may involve a higher treatment burden than standard care. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07155174 signal from an investment perspective?

This trial is investigating a novel combination therapy for a difficult-to-treat cancer, potentially addressing a significant unmet need and representing a substantial market opportunity if successful This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive one of two doses of the new drug combination or the standard treatment, and will have regular medical assessments, tests, and scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.