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Non Small Cell Lung Cancer MetastaticPhase 2KeyPemls-004NCT05599789

Pembrolizumab in Combination With Plinabulin and Docetaxel For Metastatic NSCLC After ICIs (KeyPemls-004)

A Phase 2 study testing Pembrolizumab in Combination with Plinabulin and Docetaxel in people with Non Small Cell Lung Cancer Metastatic, run by Peking Union Medical College Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase 2 Study of Pembrolizumab in Combination with Plinabulin and Docetaxel in previously treated Patients with Metastatic Non-Small Cell Lung Cancer and progressive disease (PD) after immunotherapy (Anti-PD-1/PD-L1 inhibitor) alone or in combination with Platinum-doublet Chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer Metastatic
What is being tested?
Pembrolizumab in Combination with Plinabulin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
1 Feb 2023to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male/female participants who are at least 18 years of age on the day of signing informed consent histologically confirmed diagnosis of metastatic squamous or non-squamous NSCLC (AJCC Staging Manual, version 8) will be enrolled in this study.
  • Male participants:
  • A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
  • A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 180 days after the last dose of study treatment.
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  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug.
  • Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy or in combination with platinum-doublet chemotherapy.
  • PD-1 treatment progression is defined by meeting all of the following criteria:
  • Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
  • Has demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1.
  • Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
  • Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.
  • Progression-free survival of ICIs treatment at least 6 months： PD after platinum doublet chemotherapy AND immunotherapy either sequentially or concomitantly for advanced NSCLC with negative driver gene mutations.
  • If subjects have disease progression within six months of the last dose of chemotherapy for neoadjuvant/adjuvant ICIs in combination with platinum-doublet chemotherapy for resectable NSCLC, the ICIs combination treatment can be defined as first-line treatment.
  • For unresectable stage III NSCLC subjects who received CCRT followed by ICI as maintain treatment has disease progression within 1 year of the last dose of chemotherapy, the ICIs treatments can be defined as first-line treatment.
  • Have confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days before the first dose of the study intervention.
  • Have adequate organ function as defined in the following table. Specimens must be collected within 10 days before the start of the study intervention.
  • Have a life expectancy of at least 3 months.

Who cannot join

  • Has received docetaxel or Plinabulin as monotherapy or in combination with other therapies.
  • Has received other antitumor regimens before the initiation of the study regimen for those who had disease progression after prior ICI therapy.
  • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
  • Participants must have recovered from all AEs due to previous therapies to Grade 1 or less (except alopecia). Participants with ≤Grade 2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.
  • Major surgery, open biopsy, or obvious trauma within 4 weeks before enrollment.
  • Has received prior radiotherapy within 2 weeks before the start of study intervention or has received lung radiation therapy >30 Gy within 6 months before the first dose of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
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  • Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • 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.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
  • Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression, clinically stable and without requirement of steroid treatment for at least 14 days prior to the first dose of study intervention.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab/ Plinabulin/Docetaxel and/or any of its excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by the local health authority.
  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
  • Note: Hepatitis B and C screening tests are not required unless:
  • Known history of HBV and HCV infection： As mandated by the local health authority.
  • Has known history of active TB (Bacillus Tuberculosis).
  • 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 ICF. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of trial treatment.
  • Has had an allogeneic tissue/solid organ transplant.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: A Phase 2 Study of Pembrolizumab in Combination With Plinabulin and Docetaxel in Previously Treated Patients With Metastatic Non-Small Cell Lung Cancer and Progressive Disease (PD) After Immunotherapy (Anti-PD-1/PD-L1 Inhibitor) Alone or in Combination With Platinum-doublet Chemotherapy (KeyPemls-004)

A Phase 2 Study of Pembrolizumab in Combination with Plinabulin and Docetaxel in previously treated Patients with Metastatic Non-Small Cell Lung Cancer and progressive disease (PD) after immunotherapy (Anti-PD-1/PD-L1 inhibitor) alone or in combination with Platinum-doublet Chemotherapy.

Being tested
Pembrolizumab in Combination with Plinabulin and Docetaxel
Keywords
Carcinoma, Non-Small-Cell Lung, Pembrolizumab, Plinabulin, Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab in Combination with Plinabulin and DocetaxelDrug

    Pembrolizumab 200 mg Q3W IV infusion Day 1 of each 3-week cycle; Plinabulin 30 mg/m2 Q3W IV infusion Days 1 of each 3-week cycle; Docetaxel 75 mg/m² Q3W IV infusion Day 1 of each 3-week cycle.

Study groups in NCT05599789
Study groupRoleWhat they receive
Pembrolizumab in Combination with Plinabulin and DocetaxelExperimentalPembrolizumab in Combination with Plinabulin and Docetaxel
Receives: Drug: Pembrolizumab in Combination with Plinabulin and Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR, objective response rate

    the proportion of participants who have achieved a confirmed complete response (CR) or partial response (PR), which is assessed according to RECIST 1.1 criteria.

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  1. PFS, progression-free survival

    the time from treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start1 Feb 2023
  3. Primary completion21 May 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599789
Sponsor's protocol ID
K2506
Other IDs
BPI-2358-303, MISP100168
Acronym
KeyPemls-004
Status last verified
Jul 2026
First submitted
26 Oct 2022
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in Combination with Plinabulin and Docetaxel in people with Non Small Cell Lung Cancer Metastatic, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR, objective response rate (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599789.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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