Informations générales (source: ClinicalTrials.gov)
PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Interventional
Phase 3
Pfizer (Voir sur ClinicalTrials)
septembre 2025
mars 2032
23 juillet 2026
The purpose of this study is to understand if PF-08046054 alone works well compared to
standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC)
with PD-L1 expression greater than or equal to 1% and had cancer progression during or
after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted
treatment regimen(s) for participants with known actionable genomic alterations (AGAs).
Participants in this study must have cancer that has spread through their body or can't
be removed with surgery or treated with definitive radiation.
Participants will randomly (like a flip of the coin) be assigned to either the
PF-08046054 treatment group or the docetaxel treatment group. Participants in the
PF-08046054 treatment group will receive an IV infusion (injected directly into the
veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will
receive an IV infusion once during each 21-day cycle. Study participation may be up to 5
years if the participant's NSCLC is responding to treatment. The study team will see how
each participant is doing with the study treatment during regular visits at the clinic.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | David PLANCHARD | 09/07/2026 20:25:05 | Contacter | ||
Critères
Tous
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced,
unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or
metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on
Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer
Control (UICC) Staging System. Note: Participants with a neuroendocrine component or
histology are not eligible.
- PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC)
testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or
SP263.
- Participants who have NSCLC with known AGAs are permitted.
- Able to provide any of the following tumor tissues for biomarker analysis:
- Archival specimen (preferably collected within 12 months after the last
anticancer therapy) (see laboratory manual for details); or
- De novo biopsy from a tumor lesion, if medically feasible.
- Participants must have received the following therapies and progressed during or
relapsed after receiving their most recent prior therapy, or have been intolerant to
their most recent therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
- Received a platinum-based combination therapy for the treatment of metastatic or
recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody
(concurrently or sequentially with platinum-based chemotherapy).
- Experienced disease progression within 6 months of the last dose of platinum-based
chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received
a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant
actionable mutations) must fulfill the following conditions:
- Must have received at least 1 relevant AGA-targeted therapy if locally available
and, in the opinion of the investigator, additional AGA-targeted therapy is not in
the best interest of the participant
- Received a platinum-based combination therapy for the treatment of metastatic or
recurrent disease, or experienced disease progression within 6 months of the last
dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or
chemoradiotherapy setting.
- May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with
platinum-based chemotherapy).
Exclusion Criteria
- History of another malignancy within 3 years before the first dose of PF-08046054,
or any evidence of residual disease from a previously diagnosed malignancy.
Exceptions are malignancies with a negligible risk of metastasis or death (eg,
5-year overall survival [OS] ≥90%), such as adequately treated carcinoma in situ of
the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma
in situ, or Stage I uterine cancer.
- Any central nervous system (CNS) lesions, unless definitively treated with
CNS-directed local therapy (surgery and/or radiotherapy). Participants with
definitively treated brain metastases are eligible if they meet the following
criteria:
- The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent
for at least >14 days prior to randomization (if requiring steroid treatment).
- No clinical or radiographic progression in the CNS following CNS-directed
definitive radiotherapy and/or surgery.
- Time since CNS-directed treatment is ≥28 days prior to randomization.
- Participants with a history of leptomeningeal metastasis are excluded.
- Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5
half-lives.
- Previous receipt of an MMAE-containing agent or prior docetaxel.
There are additional inclusion and exclusion criteria. The study center will determine if
criteria for participations are met.
- Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced,
unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or
metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on
Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer
Control (UICC) Staging System. Note: Participants with a neuroendocrine component or
histology are not eligible.
- PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC)
testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or
SP263.
- Participants who have NSCLC with known AGAs are permitted.
- Able to provide any of the following tumor tissues for biomarker analysis:
- Archival specimen (preferably collected within 12 months after the last
anticancer therapy) (see laboratory manual for details); or
- De novo biopsy from a tumor lesion, if medically feasible.
- Participants must have received the following therapies and progressed during or
relapsed after receiving their most recent prior therapy, or have been intolerant to
their most recent therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
- Received a platinum-based combination therapy for the treatment of metastatic or
recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody
(concurrently or sequentially with platinum-based chemotherapy).
- Experienced disease progression within 6 months of the last dose of platinum-based
chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received
a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant
actionable mutations) must fulfill the following conditions:
- Must have received at least 1 relevant AGA-targeted therapy if locally available
and, in the opinion of the investigator, additional AGA-targeted therapy is not in
the best interest of the participant
- Received a platinum-based combination therapy for the treatment of metastatic or
recurrent disease, or experienced disease progression within 6 months of the last
dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or
chemoradiotherapy setting.
- May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with
platinum-based chemotherapy).
Exclusion Criteria
- History of another malignancy within 3 years before the first dose of PF-08046054,
or any evidence of residual disease from a previously diagnosed malignancy.
Exceptions are malignancies with a negligible risk of metastasis or death (eg,
5-year overall survival [OS] ≥90%), such as adequately treated carcinoma in situ of
the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma
in situ, or Stage I uterine cancer.
- Any central nervous system (CNS) lesions, unless definitively treated with
CNS-directed local therapy (surgery and/or radiotherapy). Participants with
definitively treated brain metastases are eligible if they meet the following
criteria:
- The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent
for at least >14 days prior to randomization (if requiring steroid treatment).
- No clinical or radiographic progression in the CNS following CNS-directed
definitive radiotherapy and/or surgery.
- Time since CNS-directed treatment is ≥28 days prior to randomization.
- Participants with a history of leptomeningeal metastasis are excluded.
- Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5
half-lives.
- Previous receipt of an MMAE-containing agent or prior docetaxel.
There are additional inclusion and exclusion criteria. The study center will determine if
criteria for participations are met.