Advanced Non-squamous Non-small-cell Lung CancerPhase 2NCT06028633
Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients
A Phase 2 study testing pembrolizumab, lenvatinib and albumin-bound paclitaxel in people with Advanced Non-squamous Non-small-cell Lung Cancer and Recurrent Non-Squamous Non-Small Cell Lung Cancer, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression to first-line anti-PD-1/L1 inhibitor with platinum-doublet chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-squamous Non-small-cell Lung Cancer, Recurrent Non-Squamous Non-Small Cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
- What is being tested?
- pembrolizumab, lenvatinib and albumin-bound paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Oct 2023to Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- 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 (ICF) with histologically confirmed diagnosis of metastatic nonsquamous NSCLC (AJCC Staging Manual, Version 8) will be enrolled in this study.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants are eligible to participate the study if they agree to the following during the intervention period and for at least 180 days after the last dose of study intervention:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermia (vasectomized or secondary to medical cause) as:
- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
- Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
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- Please note that 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed D. Refrain from donating sperm for at least 120 days after the last dose of Lenvatinib.
- Female participant is eligible to participate if she is not pregnant or not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP).
- A WOCBP who agrees to follow the contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the treatment period and for at least 120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, study treatment, and agrees not to donate eggs (ova, oocytes) to others or freeze/store these for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.
- A WOCBP must have negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (i.e., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered in combination with platinum doublet chemotherapy concomitantly as first line treatment. Participants who have received Anti-PD-1/PD-L1(either as monotherapy or in combination with chemotherapy) as initial treatment at early-stage or locally advanced NSCLC should NOT be enrolled in this study. Anti-PD-1/PD-L1 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. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Eligible participants should have at least 2 pre-study images as confirmed evidence of PD (assessed by investigator) on treatment of anti-PD-1/L1 mAb before the study intervention.
- Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb,
- Have confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy. Subjects who have failed directed therapy are not eligible for the study.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Have measurable disease (at least 1 measurable lesion by CT or MRI) 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 prior to the first dose of study intervention.
- Have a life expectancy of at least 3 months and adequate organ function as defined in the following table.
- Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90mmHg and no change in antihypertensive medications within 1 week before treatment initiation.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy at any stage of disease with any anti-VEGF-TKIs (i.e. Bevacizumab, Lenvatinib, Anlotinib, Apatinib, etc.) as monotherapy or in combination with an anti-PD-1/L1 inhibitor.
- Has received prior Paclitaxel, Docetaxel or Albumin-paclitaxel as monotherapy or in combination with other therapies at any stage of disease.
- Has received prior radiotherapy within 2 weeks of 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.
- Has had major surgery within 3 weeks prior to first dose of study interventions.
- Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
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- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.
- Has radiographic evidence of major blood vessel invasion/infiltration. In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta.
- Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
- Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
- Has urine protein ≥1 g/24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing or urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria.
- Has a LVEF below the institutional (or local laboratory) normal range, as determined by echocardiogram (ECHO). OR has Prolongation of QTcF interval to >480 ms according to ECG.
- Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
- 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.
- Is 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.
- Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
- Note: Medically controlled arrhythmia would be permitted.
- 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.
- Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy. Note: The requirement for no evidence of disease for 3 years does not apply to the NSCLC for which a participant is enrolled in the study. This time requirement also does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
- 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 for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
- 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 severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a sensitivity to any of the excipients contained in Albumin-paclitaxel and/or Lenvatinib.
- Has a known history of Human Immunodeficiency Virus (HIV) infection.
- Has active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) or 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 local health authority
- 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.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital Ethics Committee
Beijing, Beijing Municipality, 100034
Rui Huang, 010-55119025, 416982188@qq.com
Shikai Wu
About this study
Official title: Efficacy and Safety of Albumin-bound Paclitaxel-Lenvatinib-Pembrolizumab in Advanced Nonsquamous NSCLC Patients After Progression to First-line Anti-PD-1/L1 Inhibitor With Platinum-doublet Chemotherapy
The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression to first-line anti-PD-1/L1 inhibitor with platinum-doublet chemotherapy. All participants will be given with albumin-bound paclitaxel, lenvatinib and pembrolizumab.
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Recurrent Non-Squamous Non-Small Cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
- Being tested
- pembrolizumab, lenvatinib, albumin-bound paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pembrolizumabDrug
Also called Keytruda
pembrolizumab 200mg IV on day 1 for every 3 weeks
lenvatinibDrug
Also called Lenvima
lenvatinib 8mg taken orally every day
albumin-bound paclitaxelDrug
Also called nab-paclitaxel, paclitaxel for injection(albumin bound)
albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Participants will receive pembrolizumab IV 200 mg D1 every 3 weeks, lenvatinib 8 mg orally every day, albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks,until disease progression, intolerable toxicity, investigator decision, or completion of 35 cycles(for pembrolizumab) and 4-6 cycles(for albumin-bound paclitaxel). Receives: Drug: pembrolizumab; Drug: lenvatinib; Drug: albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate (ORR) assessed per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
Measured: About 18 months
Secondary outcomes (4)
Overall survival
Overall survival (OS)
Measured: About 36 months
Progression-free survival
Progression-free survival (PFS) assessed per RECIST v1.1
Measured: About 24 months
Duration of response
Duration of response (DoR) assessed per RECIST v1.1
Measured: About 24 months
Treatment-related adverse events
Treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
Measured: About 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Shikai Wu, Peking University First Hospital
- Investigators
- Shikai Wu, Principal investigator, Peking Univerisity First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028633
- Sponsor's protocol ID
- MISP61001
- Status last verified
- Sep 2023
- First submitted
- 22 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Albumin-bound Paclitaxel-Lenvatinib-Pembrolizumab in Advanced Nonsquamous NSCLC Patients After Progression to First-line Anti-PD-1/L1 Inhibitor With Platinum-doublet Chemotherapy
- ClinicalTrials.gov ID
- NCT06028633
- Acronym / sponsor ID
- MISP61001
- Conditions
- Advanced Non-squamous Non-small-cell Lung Cancer, Recurrent Non-Squamous Non-Small Cell Lung Cancer, Metastatic Non-squamous Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression to first-line anti-PD-1/L1 inhibitor with platinum-doublet chemotherapy. All participants will be given with albumin-bound paclitaxel, lenvatinib and pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: pembrolizumab, Drug: lenvatinib, Drug: albumin-bound paclitaxelParticipants will receive pembrolizumab IV 200 mg D1 every 3 weeks, lenvatinib 8 mg orally every day, albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks,until disease progression, intolerable toxicity, investigator decision, or completion of 35 cycles(for pembrolizumab) and 4-6 cycles(for albumin-bound paclitaxel). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male/female participants who are at least 18 years of age on the day of signing informed consent (ICF) with histologically confirmed diagnosis of metastatic nonsquamous NSCLC (AJCC Staging Manual, Version 8) will be enrolled in this study.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male participants are eligible to participate the study if they agree to the following during the intervention period and for at least 180 days after the last dose of study intervention:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermia (vasectomized or secondary to medical cause) as:
- Female participant is eligible to participate if she is not pregnant or not breastfeeding, and at least one of the following conditions applies:
Key exclusion criteria (34 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy at any stage of disease with any anti-VEGF-TKIs (i.e. Bevacizumab, Lenvatinib, Anlotinib, Apatinib, etc.) as monotherapy or in combination with an anti-PD-1/L1 inhibitor.
- Has received prior Paclitaxel, Docetaxel or Albumin-paclitaxel as monotherapy or in combination with other therapies at any stage of disease.
- Has received prior radiotherapy within 2 weeks of 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.
- Has had major surgery within 3 weeks prior to first dose of study interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pembrolizumabAlso: Keytrudapembrolizumab 200mg IV on day 1 for every 3 weeks | Drug | Arm I |
| lenvatinibAlso: Lenvimalenvatinib 8mg taken orally every day | Drug | Arm I |
| albumin-bound paclitaxelAlso: nab-paclitaxel, paclitaxel for injection(albumin bound)albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks | Drug | Arm I |
Primary outcome
Objective response rate
Time frame: About 18 months
Objective response rate (ORR) assessed per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
4 secondary outcomes
Overall survival
Time frame: About 36 months
Progression-free survival
Time frame: About 24 months
Duration of response
Time frame: About 24 months
Treatment-related adverse events
Time frame: About 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shikai Wu principal investigator
Peking Univerisity First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pembrolizumab, lenvatinib and albumin-bound paclitaxel in people with Advanced Non-squamous Non-small-cell Lung Cancer and Recurrent Non-Squamous Non-Small Cell Lung Cancer, run by Peking University First 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 23 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shikai Wu ((86)18910715326, skywu4329@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: About 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.