Non-Squamous Non-Small Cell Lung Cancer
Conditions
Interventions
Phase2
Drug: ABBV-400 Intravenous Infusion (Dose A)
Drug: ABBV-400 Intravenous Infusion (Dose B)
Drug: ABBV-400 Intravenous Infusion (Dose A)+Osimertinib
Drug: ABBV-400 Intravenous Infusion (Dose B)+O
Sponsors
Kenji Sawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation. -Provide archived or recently obtained tumor tissue during Screening -Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. -Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. -At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated. -Central nervous system (CNS) metastasis, these should be clinically asymptomatic or stable after definitive treatment. -If the prior third-generation EGFR TKI was administered in the adjuvant setting, progression must have occurred while on treatment
Exclusion criteria
Exclusion criteria: -Tumor(s) have adenosquamous or squamous histology or sarcomatoid features. -Received more than 1 line of systemic therapy in the locally advanced or metastatic setting. -Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation. -Current, historical, or suspected interstitial lung disease (ILD)/pneumonitis that required steroids should be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Objective Response (OR) Assessed by Blinded Independent Central Review (BICR) per RECIST v1.1 Phase 3: Progression-Free Survival (PFS) as assessed by BICR per RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: PFS as assessed by BICR per RECIST v1.1 Phase 2 and 3: Overall Survival (OS) as assessed by BICR Phase 2 and 3: Duration of Response (DoR) as Assessed by the BICR per RECIST v1.1 Phase 2 and 3: Disease Control (DC) as Assessed by the BICR per RECIST v1.1 Phase 3: OR Assessed by BICR Phase 3: Percentage of Participants with Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Phase 3: Percentage of Participants with Change from Baseline in Key Lung Cancer Symptoms as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQLC13) Phase 3: Percentage of Participants with Change from Baseline in GHS/QoL as measured by the EORTC QLQ-C30 | — |
Countries
Australia, Belgium, China, France, Germany, Israel, Italy, Japan, Netherlands, Poland, Portugal, Serbia, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactContact for Patients and HCP
AbbVie G.K.
Outcome results
None listed