Telisotuzumab Adizutecan + Budigalimab for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AbbVie

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) inhibitor (budigalimab) to adult participants to treat NSCLC. ABBV-400 and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of ABBV-400 in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 4 treatment groups. Two groups will receive budigalimab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed. One group will receive the standard of care (SOC) pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 172 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or receive IV budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, or IV SOC pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Eligibility Criteria

Adults with advanced or metastatic non-squamous NSCLC who haven't had prior treatment for their advanced disease and have no actionable genomic alterations. They must have measurable disease, known PD-L1 status, adequate organ function, and may have had one systemic therapy if applicable.

Inclusion Criteria

My cancer can be measured by standard criteria.

My cancer's PD-L1 status is known.

My lung cancer is advanced or has spread and is not squamous cell type.

+3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive increasing doses of Telisotuzumab Adizutecan in combination with budigalimab until a tolerable and efficacious dose is reached

Approximately 12 weeks

Regular visits for dose adjustments and monitoring

Dose Optimization

Participants receive optimized doses of Telisotuzumab Adizutecan in combination with budigalimab or other treatment regimens

Up to 33 months

Frequent visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Participant Groups

The trial is testing Telisotuzumab Adizutecan combined with Budigalimab against standard treatments. It's in two stages: finding a safe dose of ABBV-400 with Budigalimab, then comparing different doses and combinations to the standard care involving Pembrolizumab, Pemetrexed, Carboplatin or Cisplatin.

5Treatment groups

Experimental Treatment

Group I: Part 2: Standard of CareExperimental Treatment4 Interventions

Participants will receive pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed, as part of the 33 month study duration.

Group II: Part 2 Arm 3: Budigalimab +Experimental Treatment4 Interventions

Participants will receive budigalimab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by budigalimab and pemetrexed, as part of the 33 month study duration.

Group III: Part 2 Arm 2: Telisotuzumab Adizutecan + Budigalimab Dose BExperimental Treatment2 Interventions

Participants will receive telisotuzumab adizutecan dose B in combination with budigalimab, as part of the 33 month study duration.

Group IV: Part 2 Arm 1: Telisotuzumab Adizutecan + Budigalimab Dose AExperimental Treatment2 Interventions

Participants will receive telisotuzumab adizutecan dose A in combination with budigalimab, as part of the 33 month study duration.

Group V: Part 1: Telisotuzumab Adizutecan + BudigalimabExperimental Treatment2 Interventions

Participants will receive several doses of telisotuzumab adizutecan in combination with budigalimab, as part of the 33 month study duration.