RecruitingPhase 2 / Phase 3interventionalRules rewrite

Phase 2 / Phase 3: testing Standard of Care for Non-Squamous Non-Small Cell Lung Cancer

Q: Is NCT07005102 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT07005102?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT07005102?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. this study wants to assess side effects and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy).

Official registry: https://clinicaltrials.gov/study/NCT07005102 · AbbVie · enrollment listed as 854

What this phase means

Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Standard of Care, Telisotuzumab Adizutecan, or Osimertinib (Osi). The registry lists allocation as randomized. Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control.

They plan to enroll about 854 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

Interventions: Standard of Care, Telisotuzumab Adizutecan, Osimertinib (Osi), Cisplatin, Carboplatin, Pemetrexed

Primary outcome (registry wording): Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Who it is for (from inclusion criteria)

Ages 18 Years to any
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1
Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for side effects (CTCAE) Grade 1 or baseline level (except for alopecia \[any grade\] or Grade \<= 2 peripheral neuropathy)
Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months

Who the registry excludes

History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis
Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
History of any malignancy other than disease under study except for
Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator
Successfully treated nonmelanoma skin cancer
Localized carcinoma in situ of the cervix

Public study contact (from the registry)

ABBVIE CALL CENTER

844-663-3742

abbvieclinicaltrials@abbvie.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

65 listed

Ironwood Cancer and Research Centers - Chandler /ID# 275443 — Chandler, Arizona (recruiting)
City of Hope National Medical Center /ID# 282241 — Duarte, California (recruiting)
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 284734 — Irvine, California (recruiting)
USC Norris Comprehensive Cancer Center /ID# 275343 — Los Angeles, California (recruiting)
Usc Norris Oncology/Hematology Treatment Center /ID# 278673 — Newport Beach, California (recruiting)
UCLA - Santa Monica /ID# 276816 — Santa Monica, California (recruiting)
City Of Hope - Upland /ID# 284650 — Upland, California (recruiting)
University Colorado Cancer Center /ID# 275382 — Aurora, Colorado (recruiting)
Mid Florida Hematology And Oncology Center /ID# 275278 — Orange City, Florida (recruiting)
Kaiser Permanente Moanalua Medical Center /ID# 275942 — Honolulu, Hawaii (recruiting)
The Iowa Clinic /ID# 276020 — West Des Moines, Iowa (completed)
Nho - Revive Research Institute /ID# 276115 — Lincoln, Nebraska (recruiting)

+ 47 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07005102 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07005102?

Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07005102?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary