Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, ABBV-1480, Pembrolizumab, Chemotherapy, Carboplatin, Paclitaxel, Nab-Paclitaxel
Brief summary
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.
Interventions
DRUGABBV-1480
Intravenous (IV)
DRUGPembrolizumab
Intravenous (IV)
DRUGCarboplatin
Intravenous (IV)
DRUGPaclitaxel
Intravenous (IV)
DRUGNab- Paclitaxel
Intravenous (IV)
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) assessed by the Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to Approximately 60 Months | Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of radiographic progression as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by Blinded Independent Central Review (BICR) or death from any cause, whichever occurs first. |
| Overall Survival (OS) | Up to Approximately 60 Months | Overall Survival (OS) is defined as the time from randomization to the event of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) assessed by blinded independent central review (BICR) | Up to Approximately 60 Months | ORR is defined as the percentage of participants with a confirmed Complete Response or Partial Response (PR) per investigator review according to response evaluation criteria in solid tumors (RECIST) version 1.1. |
| Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ-C30 | Up to Approximately 12 weeks | The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Participants rate items on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
| Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30. | Up to Approximately 12 Weeks | Health-related quality-of-life and symptoms will be assessed with the EORTC QLQ-C30, version 3.0. The EORTC QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a GHS/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4 point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). |
| Duration Of Response (DoR) assessed by Blinded Independent Central Review (BICR) | Up to Approximately 60 months | Duration Of Response (DoR) defined as time from the first documented Complete Response (CR) or Partial Response (PR) to the first occurrence of radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR. |
| Disease Control Rate (DCR) assessed by Blinded Independent Central Review (BICR) | Up to Approximately 60 Months | Disease Control Rate (DCR) is defined as best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) or Stable Disease (SD) based on Response Evaluation Criteria in Solid Tumors (RECIST) version1.1 |
| Time To Response (TTR) assessed by Blinded Independent Central Review (BICR) | Up to Approximately 60 months | Time To Response (TTR) is defined as the number of months from the date of first dose to the date of best overall response of Complete Response (CR) or Partial Response (PR) |
| Progression-Free Survival (PFS) assessed by the investigator | Up to Approximately 60 Months | Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier. |
| Objective Response Rate (ORR) assessed by the investigator | Up to Approximately 60 Months | Objective Response Rate (ORR) is defined as the percentage of participants with a confirmed Complete Response or Partial Response (PR) per investigator review according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. |
| Duration Of Response (DoR) assessed by the investigator | Up to Approximately 24 months | Duration Of Response (DoR) defined as time from the first documented Complete Response (CR) or Partial Response (PR) to the first occurrence of radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR. |
| DCR assessed by the investigator | Up to Approximately 60 Months | Disease Control Rate (DCR) is defined as best overall response of confirmed Complete Response (CR) or confirmed Partial Response (PR) or Stable Disease (SD) based on Response Evaluation Criteria in Solid Tumors (RECIST) version1.1 |
| TTR assessed by the investigator | Up to Approximately 60 months | Time To Response (TTR) is defined as the number of months from the date of first dose to the date of best overall response of Complete Response (CR) or Partial Response (PR) |
| Change from baseline at Week 12 in the coughing item as measured by the EORTC QLQ-LC13. | Up to Approximately 12 Weeks | The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
| Change from baseline at Week 12 in the pain in chest item as measured by the EORTC QLQLC13 | Up to Approximately 12 weeks | The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
| Change in from baseline at Week 12 in dyspnea items as measured by the EORTC QLQ-LC13 | Up to Approximately 12 weeks | The EORTC QLQ-LC13 is a lung cancer specific module and consists of 13 questions assessing lung cancer-associated symptoms and treatment-related effects, including one multiple-item scale to assess dyspnea and a series of single items assessing coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain, and pain medication. Each item is assessed on a Likert scale from 1 (not at all) to 4 (very much). |
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed