Non-Small Cell Lung CancerPhase 1/2PROPELNCT03138889
Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing NKTR-214, Pembrolizumab and Cisplatin in people with Non-Small Cell Lung Cancer, run by Nektar Therapeutics at 38 sites in 5 countries.
Trial summary
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- NKTR-214, Pembrolizumab and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 38 sitesin 5 countries
- Study dates
- 9 Jun 2017to 24 Aug 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Dose Optimization and Dose Expansion Inclusion Criteria:
- Willing and able to provide written informed consent.
- Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
- Life expectancy > 12 weeks from the time of enrollment as determined by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Oxygen saturation ≥ 92% on room air for all indications.
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- Measurable disease per RECIST 1.1.
- Patients with brain metastases are eligible if certain criteria are met.
- Availability of fresh or archival tumor tissue
- Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment
- Dose Expansion Inclusion Criteria (Non-Small Cell Lung Cancer):
- Histologically confirmed diagnosis of stage IV NSCLC.
- Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment.
- Patients with actionable mutations with approved targeted therapy in NSCLC are excluded. Testing for mutations should be performed per standard of care.
- Must not have received anti-cancer therapy for treatment of metastatic lung cancer
- Must not have received prior immunotherapy
Who cannot join
- Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
- Females who are pregnant or breastfeeding.
- Patients who have an active autoimmune disease
- History of allergy or hypersensitivity to study drug components
- Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
- Prior surgery or radiotherapy within 14 days of therapy.
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- For Dose Optimization Cohort 1 only: Chemotherapy or biological therapy within 28 days of enrollment. Targeted therapy (e.g., tyrosine kinase inhibitors) within 14 days of enrollment. Patients with ongoing AEs related to prior cancer therapies will be excluded.
- Participant's inability to adhere to or tolerate protocol or study procedures
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
United States23 sites
Augusta University - Augusta University Medical Center
Augusta, Georgia, 30912
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
St. Vincent Frontier Cancer Center
Billings, Montana, 59101
Henry Ford Hospital
Detroit, Michigan, 48202
Duke Clinical Research Institute
Durham, North Carolina, 27705
Inova Melanoma and Skin Cancer Center
Fairfax, Virginia, 22031
Highlands Oncology Group, PA - North Hills
Fayetteville, Arkansas, 72703
West Cancer Center
Germantown, Tennessee, 38138
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, 89169
Froedtert & the Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Ochsner Medical Center
New Orleans, Louisiana, 70816
New York University Langone Medical Center
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Blue Ridge Cancer Care
Roanoke, Virginia, 24153
Park Nicollet - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
California Pacific Medical Center
San Francisco, California, 94115
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63156
Northwest Medical Specialties
Tacoma, Washington, 98405
Spain7 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
HM Universitario Sanchinarro
Madrid, 28050
Hospital Universitari i Politècnic La Fe
Valencia, 46026
Germany6 sites
Vivantes Klinikum Spandau
Berlin, 13585
Asklepios Fachkliniken München-Gauting
Gauting, 82131
LungenClinic Grosshansdorf
Großhansdorf, 22927
Lungenklinik Hemer
Hemer, 58675
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Robert-Bosch-Krankenhaus
Stuttgart, 70376
About this study
Official title: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy.
The study is comprised of two groups; dose optimization and dose expansion cohorts.
Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC)
The dose expansion cohort will include first-line NSCLC patients.
Read the detailed description
NKTR-214 is a cytokine (investigational agent) that is designed to target CD122, a protein which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to expand these cells to promote their anti-tumor effects. Pembrolizumab is a programmed death receptor -1 (PD-1) blocking, fully humanized, engineered monoclonal antibody of IgG1 isotype that promotes anti-tumor effects.
The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab with or without chemotherapy. Each dose expansion cohort will enroll approximately 100 new patients.
Dose Optimization evaluated an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab given that the optimal dose and dosing schedule of NKTR-214 in combination with pembrolizumab remains unknown. The previously established recommended Phase 2 dose (0.006 mg/kg) of NKTR-214 was studied in combination with nivolumab.
Dose Expansion: NKTR-214 in combination with pembrolizumab will be evaluated in first-line non-small cell lung cancer (NSCLC). The NKTR-214 dose to be studied is 0.006 mg/kg q3w. This dose is based on the recommended phase 2 dose noted in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). Pembrolizumab will be administered at a dose of 200mg q3w. Following data review for safety and efficacy, additional patients may be dosed using the findings from the dose optimization cohorts.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- NKTR-214, Pembrolizumab, Cisplatin, Carboplatin, Nab paclitaxel
- Keywords
- NKTR-214, Metastatic Non-Small Cell Lung Cancer, Pembrolizumab, Keytruda®, NSCLC, Bempegaldesleukin
- 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.
NKTR-214Drug
Also called CD122-Biased Cytokine
NKTR-214: The dose will be 0.008 mg/kg intravenous (IV) infusion administered over 30 (± 5) minutes q3w. The maximum dose of NKTR-214 will be 0.012 mg/kg. This will include a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation based on tolerability.
PembrolizumabDrug
Also called Keytruda®
Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
NKTR-214Drug
Also called CD122-Biased Cytokine
NKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion.
NKTR-214Drug
Also called CD122-Biased Cytokine
NKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion.
CisplatinDrug
Also called Platinol®
Cisplatin will be dosed per the pharmacy manual
CarboplatinDrug
Also called Paraplatin®
Carboplatin will be dosed per the pharmacy manual
Nab paclitaxelDrug
Also called Abraxane®
Nab-paclitaxel will be dosed per local practice and label
PaclitaxelDrug
Also called Taxol®
Paclitaxel will be dosed per local practice and label
PemetrexedDrug
Also called Alimta®
Pemetrexed will be dosed per the pharmacy manual
AtezolizumabDrug
Also called Tecentriq®
Atezolizumab will be dosed per current label indication
| Study group | Role | What they receive |
|---|---|---|
| Dose Optimization, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) | Experimental | Cohort 1: NKTR-214 will be combined with pembrolizumab Receives: Drug: NKTR-214; Drug: Pembrolizumab |
| Dose Expansion, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) | Experimental | Cohort 2: NKTR-214 will be combined with pembrolizumab Receives: Drug: Pembrolizumab; Drug: NKTR-214 |
| Dose Expansion, Combo of NKTR-214 + Pembrolizumab (KEYTRUDA®) | Experimental | Cohort 3: NKTR-214 will be combined with pembrolizumab Receives: Drug: Pembrolizumab; Drug: NKTR-214 |
| Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed | Experimental | Cohort 4: NKTR-214 will be dosed in combination with pembrolizumab and either cisplatin, or carboplatin and pemetrexed, per investigator discretion Receives: Drug: Pembrolizumab; Drug: NKTR-214; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed |
| Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel | Experimental | Cohort 5: NKTR-214 will be dosed in combination with pembrolizumab and carboplatin and either nab-paclitaxel or paclitaxel, per investigator discretion Receives: Drug: Pembrolizumab; Drug: NKTR-214; Drug: Carboplatin; Drug: Nab paclitaxel; Drug: Paclitaxel |
| Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) or Atezolizumab (TECENTRIQ®) | Experimental | Cohort 0 (Before Protocol Amendment 5.0): NKTR-214 will be combined with pembrolizumab or atezolizumab Receives: Drug: Pembrolizumab; Drug: NKTR-214; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a
DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg.
A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.
Measured: DLTs were assessed at 21 days from Cycle 1
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.
Safety and Tolerability of NKTR-214 (starting at dose of 0.008 mg/kg) in combination with pembrolizumab (Keytruda®) as evaluated by incidence of drug-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to drug discontinuation, and fatal AEs.
Measured: AEs reported starting immediately after first dose of study drug(s) until 100 days after the last dose of all study drugs, up to approximately 28 months.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.
ORR per BICR by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 2 and 3.
ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR.
The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response.
Measured: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discontinue treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.
Objective Response Rate (ORR) Per Investigator's Assessment by RECIST 1.1 of NKTR-214 at a Dose of 0.006 mg/kg With Pembrolizumab and Platinum-based Chemotherapy for Dose Expansion Cohorts 4+5.
ORR per Investigator's Assessment* by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 4 +5. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response.
Objective response is the sum of confirmed complete response and confirmed partial response.
*Efficacy endpoint for Cohort 4 +5 is per Investigator's Assessment due to the early termination of the study and incompleteness of BICR data for these cohorts.
Measured: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discont. treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start9 Jun 2017
- Primary completion5 Jul 2022
- Study completion24 Aug 2022
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138889
- Sponsor's protocol ID
- 16-214-05
- Acronym
- PROPEL
- Status last verified
- Mar 2023
- First submitted
- 1 May 2017
- Last updated
- 10 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03138889
- Acronym / sponsor ID
- PROPEL / 16-214-05
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NKTR-214, Metastatic Non-Small Cell Lung Cancer, Pembrolizumab, Keytruda®, NSCLC, Bempegaldesleukin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 24 Aug 2022 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 9 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy.
The study is comprised of two groups; dose optimization and dose expansion cohorts.
Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC)
The dose expansion cohort will include first-line NSCLC patients.
Detailed description
NKTR-214 is a cytokine (investigational agent) that is designed to target CD122, a protein which is found on certain immune cells (known as CD8+ T Cells and Natural Killer Cells) to expand these cells to promote their anti-tumor effects. Pembrolizumab is a programmed death receptor -1 (PD-1) blocking, fully humanized, engineered monoclonal antibody of IgG1 isotype that promotes anti-tumor effects.
The study will evaluate the clinical benefit, safety and tolerability of combining NKTR-214 with pembrolizumab with or without chemotherapy. Each dose expansion cohort will enroll approximately 100 new patients.
Dose Optimization evaluated an every three-week dose regimen (q3w) of NKTR-214 in combination with pembrolizumab given that the optimal dose and dosing schedule of NKTR-214 in combination with pembrolizumab remains unknown. The previously established recommended Phase 2 dose (0.006 mg/kg) of NKTR-214 was studied in combination with nivolumab.
Dose Expansion: NKTR-214 in combination with pembrolizumab will be evaluated in first-line non-small cell lung cancer (NSCLC). The NKTR-214 dose to be studied is 0.006 mg/kg q3w. This dose is based on the recommended phase 2 dose noted in the monotherapy trial with NKTR-214 (Study 15-214-01, NCT02869295) and an ongoing combination trial (16-214-02, NCT02983045). Pembrolizumab will be administered at a dose of 200mg q3w. Following data review for safety and efficacy, additional patients may be dosed using the findings from the dose optimization cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Optimization, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) | Experimental | Drug: NKTR-214, Drug: PembrolizumabCohort 1: NKTR-214 will be combined with pembrolizumab |
| Dose Expansion, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) | Experimental | Drug: Pembrolizumab, Drug: NKTR-214Cohort 2: NKTR-214 will be combined with pembrolizumab |
| Dose Expansion, Combo of NKTR-214 + Pembrolizumab (KEYTRUDA®) | Experimental | Drug: Pembrolizumab, Drug: NKTR-214Cohort 3: NKTR-214 will be combined with pembrolizumab |
| Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed | Experimental | Drug: Pembrolizumab, Drug: NKTR-214, Drug: Cisplatin, Drug: Carboplatin, Drug: PemetrexedCohort 4: NKTR-214 will be dosed in combination with pembrolizumab and either cisplatin, or carboplatin and pemetrexed, per investigator discretion |
| Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel | Experimental | Drug: Pembrolizumab, Drug: NKTR-214, Drug: Carboplatin, Drug: Nab paclitaxel, Drug: PaclitaxelCohort 5: NKTR-214 will be dosed in combination with pembrolizumab and carboplatin and either nab-paclitaxel or paclitaxel, per investigator discretion |
| Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) or Atezolizumab (TECENTRIQ®) | Experimental | Drug: Pembrolizumab, Drug: NKTR-214, Drug: AtezolizumabCohort 0 (Before Protocol Amendment 5.0): NKTR-214 will be combined with pembrolizumab or atezolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent.
- Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
- Life expectancy > 12 weeks from the time of enrollment as determined by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Oxygen saturation ≥ 92% on room air for all indications.
Key exclusion criteria (9 listed)
- Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
- Females who are pregnant or breastfeeding.
- Patients who have an active autoimmune disease
- History of allergy or hypersensitivity to study drug components
- Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
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 |
|---|---|---|
| NKTR-214Also: CD122-Biased CytokineNKTR-214: The dose will be 0.008 mg/kg intravenous (IV) infusion administered over 30 (± 5) minutes q3w. The maximum dose of NKTR-214 will be 0.012 mg/kg. This will include a fixed 3+3 dose escalation followed by intra-patient step-up dose escalation based on tolerability. | Drug | Dose Optimization, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) |
| PembrolizumabAlso: Keytruda®Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual. | Drug | Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) or Atezolizumab (TECENTRIQ®), Dose Expansion, Combo of NKTR-214 + Pembrolizumab (KEYTRUDA®), Dose Expansion, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®), Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel, Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed, Dose Optimization, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) |
| NKTR-214Also: CD122-Biased CytokineNKTR-214: The dose will be 0.006 mg/kg intravenous (IV) infusion. | Drug | Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) or Atezolizumab (TECENTRIQ®), Dose Expansion, Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®), Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel, Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed |
| NKTR-214Also: CD122-Biased CytokineNKTR-214: The dose will be 0.010 mg/kg intravenous (IV) infusion. | Drug | Dose Expansion, Combo of NKTR-214 + Pembrolizumab (KEYTRUDA®) |
| CisplatinAlso: Platinol®Cisplatin will be dosed per the pharmacy manual | Drug | Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed |
| CarboplatinAlso: Paraplatin®Carboplatin will be dosed per the pharmacy manual | Drug | Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel, Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed |
| Nab paclitaxelAlso: Abraxane®Nab-paclitaxel will be dosed per local practice and label | Drug | Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel |
| PaclitaxelAlso: Taxol®Paclitaxel will be dosed per local practice and label | Drug | Dose Expansion, NKTR-214 + Pembrolizumab and Carboplatin and either Nab-paclitaxel or Paclitaxel |
| PemetrexedAlso: Alimta®Pemetrexed will be dosed per the pharmacy manual | Drug | Dose Expansion, NKTR-214 + Pembrolizumab and either Cisplatin, or Carboplatin and Pemetrexed |
| AtezolizumabAlso: Tecentriq®Atezolizumab will be dosed per current label indication | Drug | Combo of NKTR-214 + Pembrolizumab(KEYTRUDA®) or Atezolizumab (TECENTRIQ®) |
Primary outcome
Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a
Time frame: DLTs were assessed at 21 days from Cycle 1
DLTs were assesses in the Dose Optimization Cohort 1 a, which had doses of NKTR-214 as 0.008 mg/kg, 0.010 mg/kg, and 0.012 m/kg, I combination with pembrolizumab at 200 mg. A single DLT (hypotension) was reported in 1 patient in dose optimization Cohort 1a.
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] for Dose Optimization Cohort 1a.
Time frame: AEs reported starting immediately after first dose of study drug(s) until 100 days after the last dose of all study drugs, up to approximately 28 months.
Safety and Tolerability of NKTR-214 (starting at dose of 0.008 mg/kg) in combination with pembrolizumab (Keytruda®) as evaluated by incidence of drug-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to drug discontinuation, and fatal AEs.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by RECIST 1.1 of NKTR-214 Plus Pembrolizumab for Dose Expansion Cohorts 2 and 3.
Time frame: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discontinue treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.
ORR per BICR by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 2 and 3. ORR is defined as the proportion of enrolled participants who achieved a Best Overall Response (BOR) of CR or PR. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR is calculated as the sum of CR and PR. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response.
Objective Response Rate (ORR) Per Investigator's Assessment by RECIST 1.1 of NKTR-214 at a Dose of 0.006 mg/kg With Pembrolizumab and Platinum-based Chemotherapy for Dose Expansion Cohorts 4+5.
Time frame: Until disease progression, death, unacceptable toxicity, symptomatic deterioration, Investigator's decision to discont. treatment, patient withdrew consent or lost to follow-up, or study terminated by Sponsor; or until maximum of 2 years.
ORR per Investigator's Assessment* by RECIST 1.1 for the Response Evaluable Population dose expansion Cohorts 4 +5. The Response Evaluable Population was subjects who received at least 1 dose (or partial dose) of study drug, had measurable disease (per RECIST 1.1) at baseline, and had at least 1 post-baseline assessment of tumor response. Objective response is the sum of confirmed complete response and confirmed partial response. *Efficacy endpoint for Cohort 4 +5 is per Investigator's Assessment due to the early termination of the study and incompleteness of BICR data for these cohorts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Study Director study director
Nektar Therapeutics
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NKTR-214, Pembrolizumab and Cisplatin in people with Non-Small Cell Lung Cancer, run by Nektar Therapeutics at 38 sites in 5 countries.
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 16 inclusion and 9 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 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Spain, Germany, Australia, France. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 9 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing Dose-Limiting Toxicities in Dose Optimization Cohort 1a (time frame: DLTs were assessed at 21 days from Cycle 1). The study lists 4 primary outcomes in all. 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 10 Mar 2023.