Unresectable Stage III NSCLCPhase 2NCT04982549
A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC
A Phase 2 study testing Durvalumab, Carboplatin/ Paclitaxel and Pemetrexed/ Cisplatin in people with Unresectable Stage III NSCLC, run by Shandong Cancer Hospital and Institute at 2 sites in China.
Trial summary
This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Stage III NSCLC
- What is being tested?
- Durvalumab, Carboplatin/ Paclitaxel and Pemetrexed/ Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 21 Jan 2021to 1 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically or cytologically-documented NSCLC
- Locally advanced, unresectable (Stage III) NSCLC
- World Health Organization (WHO) performance status 0-1
- At least one measurable lesion, not previously irradiated
- Must have a life expectancy of at least 12 weeks at randomization
- Adequate lung function: Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or >40% predicted value and DLCO >30% predicted value
- Must provide an archived tumor tissue block(or at least 15 newly cut unstained slides)≤3 years old; if archived sample unavailable then must provide a recent(≤3 months) tumor biopsy.
Who cannot join
- Mixed small-cell and NSCLC histology
- Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
- Prior exposure to immune-mediated therapy, including but not limited to, other anti- CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.
- Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume
- Planned radiation cardiac dose V50>25%
- Any medical contraindication of platinum-based doublet chemotherapy as listed in the local labelling or known allergy/hypersensitivity to investigational product and/or its excipients
- History of the following: allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis, active primary immunodeficiency
- Uncontrolled intercurrent illness or active infection
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000
Jinming Yu, professor, 15553181309, yujinming@126.com
Feifei Teng, physician, 13075305460, tengfeifei@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Jinming YU, professor, 15553181309, yujinming@126.com
Feifei Teng, physician, 13075305460, tengfeifei16@126.com
About this study
Official title: A Prospective Study to Evaluate the Safety of Concurrent Durvalumab (MEDI4736) With Chemoradiation Therapy（CRT）Followed by Durvalumab for Chinese Unresectable Stage III Non Small Cell Lung Cancer（NSCLC）
This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Read the detailed description
Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.
- Conditions
- Unresectable Stage III NSCLC
- Being tested
- Durvalumab, Carboplatin/ Paclitaxel, Pemetrexed/ Cisplatin, Pemetrexed/ Carboplatin, Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab (intravenous infusion)
Carboplatin/ PaclitaxelDrug
Carboplatin /Paclitaxel, as per standard of care
Pemetrexed/ CisplatinDrug
Pemetrexed / Cisplatin, as per standard of care
Pemetrexed/ CarboplatinDrug
Pemetrexed / Carboplatin , as per standard of care
RadiationRadiation
5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab + platinum-based chemotherapy and radiation | Experimental | All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment. Receives: Drug: Durvalumab; Drug: Carboplatin/ Paclitaxel; Drug: Pemetrexed/ Cisplatin; Drug: Pemetrexed/ Carboplatin; Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade ≥3 immune-mediated Adverse event
Grade ≥3 immune-mediated Adverse event
Measured: From the date of first dose until disease progression,assessed up to 4 years
Secondary outcomes (6)
Progression-free survival (PFS)
Progression-free survival
Measured: From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Overall Survival (OS)
Overall Survival
Measured: From the date of first dose until death due to any cause,assessed up to 4 years
Objective response rate(ORR)
Objective response rate
Measured: From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Duration of response(DOR)
Duration of response
Measured: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years
Disease control rate(DCR)
Disease control rate
Measured: From the date of first dose until 24 weeks.
Time to death or distant metastasis(TTDM)
Time to death or distant metastasis
Measured: From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start21 Jan 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Stage III NSCLCStudies 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982549
- Sponsor's protocol ID
- D4191L00116
- Status last verified
- Aug 2021
- First submitted
- 7 May 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Safety of Concurrent Durvalumab (MEDI4736) With Chemoradiation Therapy（CRT）Followed by Durvalumab for Chinese Unresectable Stage III Non Small Cell Lung Cancer（NSCLC）
- ClinicalTrials.gov ID
- NCT04982549
- Acronym / sponsor ID
- D4191L00116
- Conditions
- Unresectable Stage III NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 29 Jul 2021 (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 a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Detailed description
Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab + platinum-based chemotherapy and radiation | Experimental | Drug: Durvalumab, Drug: Carboplatin/ Paclitaxel, Drug: Pemetrexed/ Cisplatin, Drug: Pemetrexed/ Carboplatin, Radiation: RadiationAll patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with histologically or cytologically-documented NSCLC
- Locally advanced, unresectable (Stage III) NSCLC
- World Health Organization (WHO) performance status 0-1
- At least one measurable lesion, not previously irradiated
- Must have a life expectancy of at least 12 weeks at randomization
Key exclusion criteria (8 listed)
- Mixed small-cell and NSCLC histology
- Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
- Prior exposure to immune-mediated therapy, including but not limited to, other anti- CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.
- Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume
- Planned radiation cardiac dose V50>25%
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 |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab (intravenous infusion) | Drug | Durvalumab + platinum-based chemotherapy and radiation |
| Carboplatin/ PaclitaxelCarboplatin /Paclitaxel, as per standard of care | Drug | Durvalumab + platinum-based chemotherapy and radiation |
| Pemetrexed/ CisplatinPemetrexed / Cisplatin, as per standard of care | Drug | Durvalumab + platinum-based chemotherapy and radiation |
| Pemetrexed/ CarboplatinPemetrexed / Carboplatin , as per standard of care | Drug | Durvalumab + platinum-based chemotherapy and radiation |
| Radiation5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy) | Radiation | Durvalumab + platinum-based chemotherapy and radiation |
Primary outcome
Grade ≥3 immune-mediated Adverse event
Time frame: From the date of first dose until disease progression,assessed up to 4 years
Grade ≥3 immune-mediated Adverse event
6 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of first dose until the date of objective disease progression or death,assessed up to 4 years
Overall Survival (OS)
Time frame: From the date of first dose until death due to any cause,assessed up to 4 years
Objective response rate(ORR)
Time frame: From the date of first dose until the date of objective disease progression or death,assessed up to 4 years
Duration of response(DOR)
Time frame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years
Disease control rate(DCR)
Time frame: From the date of first dose until 24 weeks.
Time to death or distant metastasis(TTDM)
Time frame: From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, Carboplatin/ Paclitaxel and Pemetrexed/ Cisplatin in people with Unresectable Stage III NSCLC, run by Shandong Cancer Hospital and Institute at 2 sites 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 7 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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jinming Yu, professor (15553181309, yujinming@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade ≥3 immune-mediated Adverse event (time frame: From the date of first dose until disease progression,assessed up to 4 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 6 Aug 2021.