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RecruitingPhase 3

A Study to Assess Intravenous ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer in Adult Participants

A Randomized, Multiregional, Open-Label Phase 3 Clinical Trial of ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ABBV-1480, an experimental drug, plus chemotherapy works better than pembrolizumab plus chemotherapy as a first treatment. It is for adults with squamous non-small cell lung cancer that has spread nearby or to distant parts of the body and cannot be treated to cure it. Both study treatments are given through a vein.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases. Squamous carcinoma accounts for 20-30% of all NSCLC cases. The purpose of this study is to determine if ABBV-1480 plus chemotherapy works better than pembrolizumab plus chemotherapy in adult participants with NSCLC. ABBV-1480 is an investigational drug being developed for the treatment of NSCLC. Participants will be randomized into 2 groups. One group will receive ABBV-1480 with platinum based chemotherapy. Another group will receive standard of care (SOC) pembrolizumab with platinum based chemotherapy. Up to approximately 940 adult participants with locally advanced (Stage IIIB/C) or metastatic (Stage IV) sqNSCLC, will be enrolled in the study in approximately 250 sites globally. In this Phase 3 study one of two groups will receive doses of Intravenous (IV) ABBV-1480 + Carboplatin \& Paclitaxel/ Nab-paclitaxel and other group will receive Intravenous (IV) Pembrolizumab + Carboplatin \& Paclitaxel/ Nab-paclitaxel. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with stage IIIB, IIIC, or IV squamous non-small cell lung cancer, confirmed by a tissue or cell test, that cannot be treated to cure it.
  • You have at least one tumor that the study team can measure on a scan.
  • If a tumor being measured was treated with radiation before, it must have grown since that treatment.
  • You can do all your usual activities, or can do light work but not hard physical activity.
  • Your blood counts, kidneys, liver, and blood clotting meet the study's requirements.
  • If you can become pregnant, you must have a negative pregnancy test.

Who can't join

  • You have already had medicine that treats cancer throughout the body for lung cancer that has spread nearby or to distant parts of the body.
  • A tissue or cell test shows that your non-small cell lung cancer is not the squamous type.
  • Your cancer has a known gene change with an approved first treatment available. These include changes in EGFR, ALK, ROS1, BRAF, NTRK, RET, or MET.
  • You have active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Adult subjects with a histologically or cytologically confirmed diagnosis of Stage IIIB, IIIC, or IV sqNSCLC that is not amenable to curative treatment * At least one lesion with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the local site investigator/radiology assessment. * Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematological, renal, hepatic, and coagulation function. * Females of childbearing potential must have a negative pregnancy test Exclusion Criteria: * Prior systemic treatment received for locally advanced or metastatic NSCLC. * Histologically or cytologically confirmed non-sqNSCLC. * Known actionable genomic alterations (including EGFR, ALK, ROS1, BRAF, NTRK, RET, and MET) for which first-line approved therapies are available. * Active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Study sites (1)

IN