NCT07361484
Docetaxel Plus Plinabulin vs Docetaxel Plus Placebo in Advanced/Metastatic Non-Squamous NSCLC After PD-1/PD-L1 Therapy and Platinum Chemotherapy (DUBLIN-4)
Not Yet Recruiting · Phase 3 · BeyondSpring Pharmaceuticals Inc. · registry updated 2026-01-23
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating docetaxel plus plinabulin versus docetaxel plus placebo in participants with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without EGFR, ALK, ROS1, or RET alterations who have experienced disease progression after prior anti-PD-1/PD-L1 immunotherapy and platinum-based chemotherapy. Approximately 442 participants will be randomized 1:1 to receive docetaxel (75 mg/m² IV on Day 1 of each 21-day cycle) in combination with plinabulin (30 mg/m² IV on Days 1 and 8) or matching placebo. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or sponsor/investigator decision. Tumor assessments will be performed regularly per RECIST v1.1, and participants will be followed for survival after treatment discontinuation. The primary objective is to compare overall survival between treatment arms; secondary objectives include evaluation of progression-free survival, objective response rate, duration of response, disease control, incidence of Grade 4 neutropenia, quality of life, and safety/tolerability.
Inclusion
- Males and females 18 years of age or older at the time of signing the ICF
- Willing and able to sign an ICF;
- Non-squamous NSCLC with EGFR, ALK, ROS and RET wild type who have been diagnosed by histopathological and/or cytological examination as being ineligible for surgical treatment and have locally advanced (stage IIIb) or metastatic (stage IV) diseases, or have recurrent and progressive disease after local treatment (if there are multiple tumor components, classify the main cell type):
- Developed disease progression after treatment with PD-1/L1 inhibitors and platinum-based chemotherapy in advanced non-squamous NSCLC with EGFR, ALK, ROS and RET wild type
- Treatment progression with anti-PD-1/L1 inhibitors and platinum-based chemotherapy administered either concurrently or sequentially as part of the same first-line treatment plan, or as two separate prior lines of systemic therapy, (does not count preoperative and adjuvant therapy) is defined to meet all of the following criteria:
- Demonstrated disease progression after anti-PD-1/L1 and platinum-based chemotherapy concurrently or sequentially as defined by RECIST v1.1
Exclusion
- Administration of chemotherapy, immunotherapy, biotherapy, targeted, or radiation therapy or investigational agent (therapeutic or diagnostic) within 3 weeks prior to the first dose of IMP. Major surgery, other than diagnostic surgery, within 4 weeks before first IMP administration is exclusionary
- Receipt of more than two prior lines of systemic anticancer therapy for locally advanced or metastatic non-small cell lung cancer. Neoadjuvant and adjuvant systemic therapies are not counted as prior lines of therapy
- Any of the following cardiac criteria experienced currently or within the last 6 months:
- Congestive heart failure (New York Heart Association ≥Class 2)
- Any clinically significant abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting ECGs, eg, complete left bundle branch block or third-degree heart block
- Acute coronary syndrome