Carcinoma, Non- Small Cell LungPhase 3MERMAID-2NCT04642469
Phase III Study to Determine Efficacy of Durvalumab in Stage II-III Non-small Cell Lung Cancer (NSCLC) After Curative Intent Therapy.
A Phase 3 study testing Durvalumab in people with Carcinoma, Non- Small Cell Lung, run by AstraZeneca at 115 sites in 25 countries.
Trial summary
This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Carcinoma, Non- Small Cell Lung
- What is being tested?
- Durvalumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 115 sitesin 25 countries
- Study dates
- 30 Nov 2020to 15 Jan 2024
- Phase
- Phase 3
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses.
- Provision of signed and dated written optional genetic informed consent prior to collection of the optional sample for genetic analysis. This consent should be signed at the time of second screening. This optional sample and analyses are separate from the mandatory genetic testing consent included in ICF1.
- The following criteria must have been met at the time of surgery or at the time of the curative intent therapy (first screening):
- Age ≥18 years at the time of screening (ICF1);
Show all 37Show fewer
- Male and/or female
- Histologically confirmed NSCLC with resectable stage II-III disease who have undergone curative intent therapy (complete resection of the primary tumor ± neoadjuvant and/or adjuvant therapy) per SoC.
- Select stage IIIB (ie, T3N2 or T4N2) patients will be eligible, provided they are upstaged to T3N2 or T4N2 based on confirmed pathology after surgery. Patients who are staged as T3N2 or T4N2 prior to surgery are not eligible.
- A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and adrenal glands) along with brain MRI (preferred) or brain CT with IV contrast must have been done for surgical planning prior to surgery. It is recommended that patients undergo combined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan (computerized tomography) within the 6 weeks prior to surgery in order to rule out detectable extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. If the positron emission tomography (PET) scan was not performed, or data from a PET is not available, patients may still be enrolled into the study provided appropriate imaging (CT/MRI) is performed prior to randomization.
- Complete resection of the primary NSCLC is mandatory. Invasive (pre-operative or intra-operative) exploration of hilar and mediastinal lymph nodes must have been performed to confirm primary tumor nodal status (prior to or after surgery). Surgical resection of the primary NSCLC can occur by open thoracotomy or by video-assisted thoracic surgery (VATs) and resection can be achieved by segmentectomy, lobectomy, sleeve resection, bilobectomy or pneumonectomy. Patients undergoing wedge resection are not eligible for this study.
- Criteria for prior systemic chemotherapy/radiotherapy:
- Patients should have completed (or be undergoing) curative intent therapy (surgery ± neoadjuvant and/or adjuvant therapy; adjuvant therapy can include PORT) with exceptions noted below:
- Patients who discontinue chemotherapy and/or PORT for toxicity prior to completion of all planned therapy are eligible.
- Patients who have not received any neoadjuvant and/or adjuvant chemotherapy, and meet all other eligibility criteria, may be eligible under the following circumstances:
- All patients who are eligible for adjuvant chemotherapy MUST be offered adjuvant chemotherapy.
- The patient has declined adjuvant chemotherapy, and in the opinion of the Investigator, this is the patient's final decision after receiving appropriate information and adequate time to make the decision. The patient's refusal of adjuvant chemotherapy must be documented.
- If in the view of the Investigator, adjuvant chemotherapy is contraindicated due to an underlying intercurrent illness/laboratory abnormality, which is not considered reversible within a reasonable timeframe for the patient to be eligible for adjuvant therapy, which must be documented.
- Criteria assessed prior to and at the start of surveillance:
- Confirmation of suitable biosamples for WES and central PD-L1 testing. Resected tumor tissue and whole blood samples must be provided to the diagnostic laboratory for WES of tumor and germline DNA, respectively as soon as possible following pathology confirmation. Samples must be sent no later than 1-2 weeks after completion of adjuvant therapy or 3-5 weeks after surgery (if no adjuvant therapy is given) for development of the Sponsor-approved personalized panel for MRD detection at a central reference laboratory. Germline sequencing of whole blood is mandatory. Resected tumor tissue must also be provided for PD-L1 testing at a central reference laboratory (see inclusion criteria 15).
- Post-adjuvant therapy or post-surgery (if no adjuvant therapy is given) CT scan of the chest and abdomen (including liver and adrenal glands) and brain MRI [preferred] or brain CT with IV contrast should be available to confirm no evidence of metastasis. If scans were not performed post-curative intent therapy, additional scans must be done prior to start of surveillance.
- Consents to be accessible for q6w±3d plasma sample collection for MRD evaluation and for q12w±1w CT scans during the 96-week surveillance period.
- The plasma sample that marks the start of surveillance must be collected 8±1 weeks after completion of adjuvant therapy (if administered) or 12±1 weeks after surgery (where adjuvant therapy is not given).
- A patient who is determined to be MRD- based on analysis of this plasma sample (ie, MRD- at the start of surveillance) may continue in surveillance provided all other eligibility criteria are met.
- A patient who is determined to be MRD+ based on analysis of this plasma sample (ie, MRD+ at the start of surveillance) may be eligible for immediate randomization provided all other eligibility criteria are met.
- A patient who becomes MRD+ during surveillance is eligible to enter the second screening period and may be randomized in the study if all other eligibility criteria are met.
- Criteria for second screening prior to randomization to treatment:
- CT scan of the chest and abdomen (including liver and adrenal glands) and brain MRI [preferred] or brain CT with IV contrast performed within the 28 days ± 7 days prior to randomization to confirm no evidence of RECIST 1.1-defined disease recurrence and/or metastasis.
- Known tumor PD-L1 status determined at a central reference laboratory testing service using a validated Ventana SP263 PD-L1 immunohistochemistry (IHC) assay prior randomization. Patients with unknown PD-L1 status are not eligible for the study.
- WHO/Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Complete post-operative wound healing must have occurred prior to randomization; patients must have recovered from all acute, reversible toxic effects from prior treatments (excluding alopecia) that could potentially adversely impact further administration of durvalumab/placebo according to the Investigator's judgment.
- Must have recovered from all acute, reversible toxic effects from chemotherapy that could potentially adversely impact further administration of durvalumab or placebo according to the Investigator's judgment
- Adequate organ and marrow function as described in the protocol.
- Must have a life expectancy of at least 12 weeks Weight
- Body weight >30 kg Inclusion criteria assessed prior to entering the observation period
- No evidence of RECIST 1.1-defined disease recurrence or metastasis confirmed by CT scan of the chest and abdomen (including liver and adrenal glands) and a brain MRI (preferred) or brain CT with IV contrast.
- MRD- status, as determined by testing the last plasma sample collected during the 96-week surveillance period.
Who cannot join
- Diagnostics assessments:
- EGFR and/or ALK mutant as assessed either from the tumor biopsy taken prior to surgery or the resected tumor tissue. Testing must be performed using a wellvalidated, local regulatory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable.
- Mixed small cell and NSCLC histology.
- Require re-resection or are deemed to have unresectable NSCLC by amultidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice.
- Baseline imaging demonstrating unequivocal evidence of RECIST 1.1-defined disease recurrence or evidence of clinical recurrence outside of imaging prior to randomization. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded.
- Medical conditions
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- History of allogeneic organ or bone marrow transplantation.
- Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or
- Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in-situ without evidence of disease
- History of active primary immunodeficiency
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B virus (HBV) (known positive HBV surface antigen (HBsAg) result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Known allergy or hypersensitivity to any of the IPs or any of the IP excipients Prior/concomitant therapy
- Received any IO therapy in the adjuvant setting or any prior exposure to durvalumab.
- Received any radiotherapy in the neoadjuvant setting.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) Prior/concurrent clinical study experience
- Previous IP assignment in the present study
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
- Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Other exclusions
- Female patients who are pregnant or breastfeeding.
- Female patients who become pregnant during the study will be withdrawn from surveillance and are not eligible for randomization.
- Male or female patients of reproductive potential who are not willing to employ effective birth control at the time of entry into second screening (initiated with the signing of ICF2a) until 90 days after the last dose of IP (See Appendix H).
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements
Trial locations and contacts
115 sites in 25 countries.
115 sites in 25 countries
United States10 sites
Research Site
Daytona Beach, Florida, 32117
Research Site
Gainesville, Florida, 32605
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90089
Research Site
Louisville, Kentucky, 40241
Research Site
Minneapolis, Minnesota, 55404
Research Site
Nashville, Tennessee, 37203
Research Site
Punta Gorda, Florida, 33980
Research Site
Salt Lake City, Utah, 84112
Research Site
Spartanburg, South Carolina, 29303
Japan10 sites
Research Site
Bunkyō City, 160-0023
Research Site
Hiroshima, 734-8551
Research Site
Kashiwa, 277-8577
Research Site
Kōtoku, 135-8550
Research Site
Osaka, 534-0021
Research Site
Osaka, 541-8567
Research Site
Sakaishi, 591-8555
Research Site
Sendai, 980-0873
Research Site
Sunto-gun, 411-8777
Research Site
Yokohama, 241-8515
Hungary7 sites
Research Site
Budapest, 1083
Research Site
Budapest, 1121
Research Site
Gyöngyös - Mátraháza, 3200
Research Site
Győr, 9024
Research Site
Székesfehérvár, 8000
Research Site
Szolnok, 5004
Research Site
Törökbálint, 2045
Spain7 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 08041
Research Site
Madrid, 28041
Research Site
Málaga, 29010
Research Site
Oviedo, 33011
Research Site
Pamplona, 31008
Research Site
Santiago de Compostela, 15706
Taiwan7 sites
Research Site
Chiayi City, 613
Research Site
Kaohsiung City
Research Site
Taichung, 40201
Research Site
Tainan, 70403
Research Site
Taipei, 11217
Research Site
Taipei, 235
Research Site
Taoyuan, 333
Greece6 sites
Research Site
Athens, 11526
Research Site
Athens, 11527
Research Site
Heraklion, 71110
Research Site
Holargos, Athens, 155 62
Research Site
Larissa, 41110
Research Site
Thessaloniki, 54645
Italy6 sites
Research Site
Meldola, 47014
Research Site
Milan, 20133
Research Site
Monza, 20052
Research Site
Orbassano, 10043
Research Site
Roma, 00144
Research Site
Rozzano, 20089
Brazil5 sites
Research Site
Barretos, 14784-400
Research Site
Florianópolis, 88034-000
Research Site
Porto Alegre, 90610-000
Research Site
São José do Rio Preto, 15090-000
Research Site
Vitória, 29043-260
Canada5 sites
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Montreal, Quebec, H4A 3J1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Saint John, New Brunswick, E2L 4L2
Research Site
Victoria, British Columbia, V8R 6V5
Israel5 sites
Research Site
Haifa, 31096
Research Site
Jerusalem, 91120
Research Site
Kfar Saba, 4428164
Research Site
Petah Tikva, 49100
Research Site
Ramat Gan, 52621
Russia5 sites
Research Site
Moscow, 105229
Research Site
Moscow, 115478
Research Site
Novosibirsk, 630108
Research Site
Saint Petersburg, 191036
Research Site
Saint Petersburg, 197758
South Korea5 sites
Research Site
Cheongju-si, 28644
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Suwon, 16247
Turkey (Türkiye)5 sites
Research Site
Adana, 01120
Research Site
Ankara, 06010
Research Site
Istanbul, 34010
Research Site
Istanbul, 34214
Research Site
Malatya, 44280
France4 sites
Research Site
Marseille, 13915
Research Site
Pessac, 33604
Research Site
Saint-Herblain, 44805
Research Site
Strasbourg, 67091
Poland4 sites
Research Site
Bydgoszcz, 85-796
Research Site
Gdansk, 80-214
Research Site
Tomaszów Mazowiecki, 97-200
Research Site
Warsaw, 02-781
Australia3 sites
Research Site
Camperdown, 2050
Research Site
Melbourne, 3000
Research Site
St Leonards, 2065
Czechia3 sites
Research Site
Olomouc, 77900
Research Site
Ostrava, 703 00
Research Site
Prague, 128 08
Netherlands3 sites
Research Site
Breda, 4818 CK
Research Site
Maastricht, 6202 AZ
Research Site
Zwolle, 8025 AB
Singapore3 sites
Research Site
Singapore, 119228
Research Site
Singapore, 169610
Research Site
Singapore, 308433
Vietnam3 sites
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 70000
Research Site
Hochiminh, 70000
About this study
Official title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.
This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.
Read the detailed description
This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during surveillance period.
- Conditions
- Carcinoma, Non- Small Cell Lung
- Being tested
- Durvalumab, Placebo
- Keywords
- NCSLC, Double-blind, PD-L1, MEDI4736, Durvalumab, DFS, OS, MRD+, Lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Medi4736
Intravenous administration of Durvalumab
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab | Experimental | Intravenous administration of Durvalumab Receives: Drug: Durvalumab |
| Placebo | Placebo comparator | Intravenous administration of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
DFS was defined as the time from the date of randomization until any one of the following events, whichever occurred first: Date of disease recurrence using Investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 OR Date of death from any cause.
Measured: Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 months
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An adverse event was any untoward medical occurrence (other than progression of the malignancy under evaluation) in a participant or clinical study participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An SAE was an AE that occurred during any study phase and fulfilled one or more of the following criteria: Resulted in death, was immediately life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect, was an important medical event that might jeopardize the participant or might require medical treatment to prevent one of the outcomes listed above, AEs for malignant tumors reported during a study, malignant tumors that - as part of normal, if rare, progression - underwent transformation.
Measured: From start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start30 Nov 2020
- Primary completion31 May 2023
- Study completion15 Jan 2024
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 Carcinoma, Non- Small Cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Spigel, Principal investigator, SCRI Development Innovations, LLCCharles Swanton, Principal investigator, Francis Crick Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642469
- Sponsor's protocol ID
- D910MC00001
- Other IDs
- 2020-000612-30
- Acronym
- MERMAID-2
- Status last verified
- May 2024
- First submitted
- 3 Nov 2020
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.
- ClinicalTrials.gov ID
- NCT04642469
- Acronym / sponsor ID
- MERMAID-2 / D910MC00001
- Conditions
- Carcinoma, Non- Small Cell Lung
- Keywords
- NCSLC, Double-blind, PD-L1, MEDI4736, Durvalumab, DFS, OS, MRD+
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 25 Jun 2024
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 Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.
Detailed description
This is a Phase III, randomized, multicenter, double-blind, placebo-controlled, study to evaluate the efficacy and safety of durvalumab adjuvant therapy compared to placebo in patients with completely resected stage II-III NSCLC who have undergone curative intent therapy (complete resection ± neoadjuvant and/or adjuvant therapy), who have no evidence of Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1-defined disease recurrence, and who become MRD+ during surveillance period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durvalumab | Experimental | Drug: DurvalumabIntravenous administration of Durvalumab |
| Placebo | Placebo comparator | Other: PlaceboIntravenous administration of placebo |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Informed consent
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICFs and in the protocol.
- Provision of signed and dated, written informed consent form prior to any mandatory study-specific procedures, sampling, and analyses.
- Provision of signed and dated written optional genetic informed consent prior to collection of the optional sample for genetic analysis. This consent should be signed at the time of second screening. This optional sample and analyses are separate from the mandatory genetic testing consent included in ICF1.
- The following criteria must have been met at the time of surgery or at the time of the curative intent therapy (first screening):
Key exclusion criteria (32 listed)
- EGFR and/or ALK mutant as assessed either from the tumor biopsy taken prior to surgery or the resected tumor tissue. Testing must be performed using a wellvalidated, local regulatory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable.
- Mixed small cell and NSCLC histology.
- Require re-resection or are deemed to have unresectable NSCLC by amultidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice.
- Baseline imaging demonstrating unequivocal evidence of RECIST 1.1-defined disease recurrence or evidence of clinical recurrence outside of imaging prior to randomization. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded.
- Medical conditions
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: Medi4736Intravenous administration of Durvalumab | Drug | Durvalumab |
| PlaceboPlacebo Comparator | Other | Placebo |
Primary outcome
Disease-free Survival (DFS)
Time frame: Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 months
DFS was defined as the time from the date of randomization until any one of the following events, whichever occurred first: Date of disease recurrence using Investigator assessments according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 OR Date of death from any cause.
1 secondary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From start of study treatment (Day 1) up to 90 days after last dose of study treatment, approximately 21.4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSPLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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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.
David Spigel principal investigator
SCRI Development Innovations, LLC
Charles Swanton principal investigator
Francis Crick Institute
115 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Durvalumab in people with Carcinoma, Non- Small Cell Lung, run by AstraZeneca at 115 sites in 25 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 37 inclusion and 32 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States, Japan, Hungary, Spain, Taiwan and 20 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Jun 2024). 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?
Disease-free Survival (DFS) (time frame: Every 8 weeks (q8w) ± 1 week until Week 48, then every 12 weeks (q12w) ± 1 week until appearance of RECIST 1.1-defined disease recurrence or follow-up, up to 16.6 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 25 Jun 2024.