Carcinoma, Non-Small-Cell LungPhase 2NCT04515979
Vactosertib in Combination with Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
A Phase 2 study testing Vactosertib 300 mg BID and pembrolizumab 200 mg IV in people with Carcinoma, Non-Small-Cell Lung, run by MedPacto, Inc. at 1 site in South Korea.
Trial summary
This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Vactosertib 300 mg BID and pembrolizumab 200 mg IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2020to 5 Aug 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a histologically- or cytologically-documented NSCLC advanced or stage IV lung cancer
- Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated
- Have measurable disease based on RECIST 1.1
- PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay
- Have a life expectancy of at least 3 months.
- ECOG 0 or 1
- Subjects must be able to swallow tablets and absorb vactosertib.
- Have adequate organ function as indicated by the following laboratory values in
Who cannot join
- Is currently participating in a study of an investigational agent
- Has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /Had major surgery / radiation therapy to the lung
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is taking prohibited medications
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Had a severe hypersensitivity reaction to treatment with another mAb previously.
- Has severe hypersensitivity to vactosertib and/or any of its excipients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of Vactosertib in Combination with Pembrolizumab As a First-line Treatment for Subjects with PD-L1 Positive Advanced Non-Small Cell Lung Cancer
This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.
Read the detailed description
Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay performed according to local laboratory regulations prior to study enrollment.
Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease.
Eligible subjects will receive:
- Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Vactosertib 300 mg BID and pembrolizumab 200 mg IV
- 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.
Vactosertib 300 mg BID and pembrolizumab 200 mg IVDrug
Also called Vactosertib 300 mg BID and keytruda 200 mg IV
Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| vactosertib+Pembrolizumab | Experimental | Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks Receives: Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR per RECIST 1.1
ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start17 Dec 2020
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Why it stopped: This is because Medpacto decided to modify its development strategy as the business and development environment changed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedPacto, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minkyu Heo, Study director, MedPacto, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515979
- Sponsor's protocol ID
- MP-VAC-205
- Other IDs
- MK3475 B37
- Status last verified
- Dec 2024
- First submitted
- 11 Aug 2020
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of Vactosertib in Combination with Pembrolizumab As a First-line Treatment for Subjects with PD-L1 Positive Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04515979
- Acronym / sponsor ID
- MP-VAC-205
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is because Medpacto decided to modify its development strategy as the business and development environment changed.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- MedPacto, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 17 Aug 2020 (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.
This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.
Detailed description
Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay performed according to local laboratory regulations prior to study enrollment.
Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease.
Eligible subjects will receive:
- Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vactosertib+Pembrolizumab | Experimental | Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IVVactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a histologically- or cytologically-documented NSCLC advanced or stage IV lung cancer
- Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated
- Have measurable disease based on RECIST 1.1
- PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay
- Have a life expectancy of at least 3 months.
Key exclusion criteria (8 listed)
- Is currently participating in a study of an investigational agent
- Has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /Had major surgery / radiation therapy to the lung
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is taking prohibited medications
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
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 |
|---|---|---|
| Vactosertib 300 mg BID and pembrolizumab 200 mg IVAlso: Vactosertib 300 mg BID and keytruda 200 mg IVVactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W). | Drug | vactosertib+Pembrolizumab |
Primary outcome
ORR per RECIST 1.1
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators
Results and safety
The study was stopped early (reason given: This is because Medpacto decided to modify its development strategy as the business and development environment changed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- 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.
Minkyu Heo study director
MedPacto, Inc.
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 Vactosertib 300 mg BID and pembrolizumab 200 mg IV in people with Carcinoma, Non-Small-Cell Lung, run by MedPacto, Inc. at 1 site in South Korea.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 Dec 2024. 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 South Korea. 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?
The study was stopped early (reason given: This is because Medpacto decided to modify its development strategy as the business and development environment changed.). Results are not available in the source record.
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 per RECIST 1.1 (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years). 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 9 Dec 2024.