New drug combo aims to boost survival in advanced lung cancer

NCT ID NCT02504489

Disease control Sponsor: BeyondSpring Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding plinabulin to the chemotherapy drug docetaxel helps people with advanced non-small cell lung cancer live longer. 559 participants who had already tried one or two prior treatments received either the combination or docetaxel alone. The study measured overall survival, tumor response, and side effects like severe neutropenia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: docetaxel and plinabulin
What this could lead to: If successful, this combination could improve survival and reduce severe side effects for people with advanced lung cancer who have already tried other treatments.
What could go wrong: This is a completed phase 3 trial, but results may not show a significant benefit over standard care. The drug combination may also cause side effects like low white blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

559 people

The number who actually took part.

Started

Dec 2015

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: 1. Males and females ≥ 18 years of age 2. ECOG performance status ≤ 2. 3. Histopathologically or cytologically confirmed non-squamous or squamous NSCLC. 4. Disease progression during or after treatment with one or two treatment regimen(s) Treatment regimens can be chemotherapy, targeted therapy, biological therapy, or immunotherapy for advanced (Stage IIIB) or metastatic disease (Stage IV). Modification of a regimen to manage toxicity with a different drug does not constitute a new regimen. Maintenance therapy following platinum-based chemotherapy is not considered as a separate regimen. Adjuvant or neoadjuvant chemotherapy and/or chemo-radiation for early stage disease do not count as prior systemic therapy. Prior radiation therapy is not exclusionary. Prior immunotherapy with a PD-1/PD-L1 inhibitor is not exclusionary. Prior treatment for advanced or metastatic disease must have included a platinum-based regimen. (Treatment of early stage disease \[Stage IIIA or earlier\] with a platinum-containing therapy does not count). 5. Patients with active brain metastasis or leptomeningeal involvement with brain metastases who are asymptomatic, and whose lesions by imaging are at least stable and without interim development of new lesions for at least 4 weeks may be enrolled. Patients who require continued therapy with steroid medication for management for their brain metastases are eligible; dosing must be stable for at least 4 weeks prior to randomization; 6. Patients must have at least one measurable lung lesion of ≥10 mm by CT or MRI per RECIST 1.1 criteria. Radiographic tumor assessment is to be performed within 28 days prior to randomization; 7. All patients with non-squamous NSCLC must have been tested for 19 deletion and exon 21 L858R substitution mutation. Only patients without EGFR sensitizing mutations are eligible, and they must have progressed on platinum-based chemotherapy. Patients with known ALK-rearrangements should be treated with an appropriate tyrosine kinase inhibitor (TKI) before entering the study. The TKI regimen would count as a line of treatment. 8. All adverse events of any prior systemic therapy, surgery, or radiotherapy, must have resolved to CTCAE (v4.03) Grade ≤2, except for neurological adverse events that must have resolved to Grade ≤1; 9. The following laboratory results from the central laboratory within 14 days prior to Cycle 1 Day 1 study drug administration. * Hemoglobin ≥9 g/dL independent of transfusion or growth factor support; * Absolute neutrophil count ≥1.5 x 109/L independent of growth factor support; * Platelet count ≥100 x 109/L independent of transfusion or growth factor support; * Serum total bilirubin ≤ ULN, unless the patient has a diagnosis of Gilbert's disease in which case serum bilirubin ≤3.0 times ULN; * AST and ALT ≤2.5 x ULN (≤1.5 x ULN if alkaline phosphatase is \>2.5 x ULN); * Serum creatinine ≤1.5 x ULN; 10. Life expectancy more than 12 weeks; 11. Female patients of childbearing potential have a negative pregnancy test at baseline. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression. 1. Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within the 24-hour period prior to the first dose of study drug. 2. Sexually active women of childbearing potential enrolled in the study must agree to use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of study drug. Effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) a vasectomized partner. 3. For male patients who are sexually active and who are partners of premenopausal women: agreement to use two forms of contraception as in criterion 11b above during the treatment period and for at least 3 months after the last dose of study drug. 12. Signed informed consent. EXCLUSION CRITERIA: Patients with any of the following: 1. Administration of chemotherapy, immunotherapy, biological, targeted, or radiation therapy or investigational agent (therapeutic or diagnostic) within 3 weeks prior to receipt of study medication. Major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. 2. Significant cardiac history: * History of myocardial infarction or ischemic heart disease within 1 year (within a window of 18 days) before first study drug administration; * Uncontrolled arrhythmia; * History of congenital QT prolongation; * ECG findings consistent with active ischemic heart disease; * New York Heart Association Class III or IV cardiac disease; * Uncontrolled hypertension: blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic in spite of antihypertensive medication. 3. Patients who have received prior treatment with docetaxel. 4. Prior transient ischemic attack or cerebrovascular accident within the past year (within an 18-day window). Any neurologic toxicities ≥ Grade 2 within 3 weeks of randomization. 5. History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease. (Concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable). History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility. 6. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy. 7. Known infection with human immunodeficiency virus (HIV) or active hepatitis A, B, or C. 8. Known prior hypersensitivity reaction to any product containing polysorbate 80, polyoxyethylene 15 hydroxystearate/Macrogol 15 hydroxystearate (Solutol HS 15/ Kolliphor HS 15). 9. Female subject who is pregnant or lactating. 10. Second malignancy unless in remission for \>5 years. (Non-melanoma skin cancer or carcinoma in situ of the cervix treated with curative intent is not exclusionary). 11. Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include uncontrolled diabetes, infection requiring parenteral anti-infective treatment, liver failure, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent form. 12. Unwilling or unable to comply with procedures required in this protocol.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

527-Linyi Cancer Hospital

Linyi, Shangdong, 276000, China
Adult Mater Hospital

South Brisbane, Queensland, 4101, Australia
Affiliated Cancer Hospital of Harbin Medical Unive

Harbin, Heilongjiang, 150040, China
Affiliated Tumor Hospital of Xinjiang Medical Univ

Ürümqi, Xinjiang, 830011, China
Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States
Anhui Provincial Hospital

Hefei, Anhui, 230000, China
Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China
Blacktown Cancer Centre

Blacktown, New South Wales, 2148, Australia
Border Medical Oncology Research Unit

East Albury, New South Wales, 2640, Australia
Cancer Center of Central Connecticut

Plainville, Connecticut, 06062, United States
Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China
Carle Cancer Center

Urbana, Illinois, 61801, United States
Central Care Cancer Center

Bolivar, Missouri, 65613, United States
Cookeville Regional Medical Center Cancer Center

Cookeville, Tennessee, 61801, United States
Epworth Hospital

Richmond, Victoria, 3121, Australia
Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia
Gosford Hospital

Gosford, New South Wales, 2250, Australia
Guizhou Provincial Hospital

Guiyang, Guizhou, 550002, China
Hattiesburg Clinic Hematology/Oncology

Hattiesburg, Mississippi, 39401, United States
Henan Cancer Hospital

Zhengzhou, Henan, 450008, China
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Innovative Clinical Research Institute

Whittier, California, 90603, United States
Ironwood Cancer & Research Centers

Chandler, Arizona, 85224, United States
Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China
Jiangxi Provincial Tumor Hospital

Nanchang, Jiangxi, 330000, China
Jiangyin People's Hospital

Jiangyin, Jiangsu, 214400, China
Jilin Province Cancer Hospital

Changchun, Jilin, 100013, China
Kansas University Medical Center

Westwood, Kansas, 00913, United States
Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110042, China
Memorial Health Care System

Colorado Springs, Colorado, 80909, United States
Michigan Center of Medical Research

Farmington Hills, Michigan, 48334, United States
Nantong Tumor Hospital

Nantong, Jiangsu, 226361, China
Orchard Healthcare Research Inc.

Skokie, Illinois, 60077, United States
Pacific Cancer Medical Center, Inc.

Anaheim, California, 92801, United States
Peachtree Hematoloy-Oncology Consultants, PC

Atlanta, Georgia, 30318, United States
Peninsula and South East Oncology

Melbourne, Victoria, 3199, Australia
Perth Oncology/Mount Hospital

Perth, Western Australia, 6000, Australia
Shandong Cancer Hospital

Jinan, Shangdong, 250117, China
Shanghai Chest Hospital, Shanghai Jiaotong Univers

Shanghai, Shanghai Municipality, 200030, China
Sir Run Run Shaw Hospital, Zhejiang University

Hangzhou, Zhejiang, 310016, China
St John of God Hospital, Subiaco

Subiaco, Western Australia, 6008, Australia
The Fifth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200240, China
The First Affiliated Hospital of Xi'an Jiaotong U

Xi'an, Shaanxi, 710061, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China
The First Affiliated Hospital, Zhejiang University

Hanzhou, Zhejiang, 310003, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China
The PLA General Hospital

Beijing, Beijing Municipality, 100853, China
The Second Xiangya Hospital of Central South Unive

Changsha, Hunan, 410011, China
Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300060, China
Toledo Cancer Center

Toledo, Ohio, 43623, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Louisville-Brown Cancer Center

Louisville, Kentucky, 40202, United States
Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States
West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China
Yantai Yuhuangding Hospital

Yantai, Shangdong, 264000, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China
Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361000, China

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