Superior Sulcus TumorPhase 3DEEP_OCEANNCT04465968
Efficacy and Safety of CRT, Durvalumab and Surgery for SST
A Phase 3 study testing Cisplatin, S1 and concurrent radiotherapy in people with Superior Sulcus Tumor and Non-small Cell Lung Cancer Stage IIB, run by National Cancer Center Hospital East.
Trial summary
The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Superior Sulcus Tumor, Non-small Cell Lung Cancer Stage IIB, Non Small Cell Lung Cancer Stage III
- What is being tested?
- Cisplatin, S1 and concurrent radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from the primary lesion.
- Meet all of the following (UICC-TNM classification 8th edition). I. Regarding the primary lesion, meet one of the following on chest CT. i. Direct invasion of the chest wall at or above the height of the first rib (at least invasion of the parietal pleura) ii. Direct invasion of the subclavian artery or vein II. Regarding regional lymph nodes, meet either of the following by chest CT and FDG-PET/CT. Metastasis is also considered if lymph node metastasis is determined by either chest CT or FDG-PET/CT.
- cN0 ii. cN1 and no metastases to #10, #11, and #12 lymph nodes iii. cN3 (ipsilateral supraclavicular lymph node metastasis) and no metastases in regional lymph nodes (N1 and N2) other than "#13, #14 lymph nodes" III. No distant metastases (including intrapulmonary metastases in the same ling lobe and in a different lung lobe on the same side) on imaging tests including FDG-PET/CT
- It is judged that radical resection is possible by lobectomy (including bilobectomy for 2 lobes), which satisfies the following [1] and [2].
- The board respiratory surgeon judges that none of the following is true based on the image findings.
- There is vertebral body infiltration that requires total spondylectomy ii. Presence of spinal cord infiltration iii. Invaded trachea or tracheal bifurcation iv. Invasion of aortic arch or ascending aorta v. Invading brachial plexus at C8 or higher vi. Esophageal infiltration that requires esophageal reconstruction for resection vii. Pneumonectomy is required for radical resection II. Meet all of the following. i. Predicted postoperative forced expiratory volume of 1 second (FEV1.0) ≥ 800 mL within 56 days before registration ii. SpO2 > 93% (room air) with the latest inspection value within 14 days before registration
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- Consult with the radiotherapy doctor and it is judged that all of the following are met.
- Radiation therapy is possible according to the protocol II. The irradiation field does not reach the hilum
- The age of the registration date is 20 years or older and 75 years or yonger.
- Performance status (PS) is 0 or 1 according to ECOG standards (PS must be described in medical records)
- The presence or absence of measurable lesions is not required.
- No history of following surgery irrespective of whether for a benign or malignant lesion.
- Thoracoscopic surgery or thoracotomy with excision of the affected lung or esophagus or mediastinum (however, a history of thoracoscopic surgery without wedge resection or lung, esophagus, or mediastinal resection (eg, pleural biopsy)) is allowed) II. Median sternotomy surgery (with or without organ resection) III. Pulmonary resection other than wedge resection of the contralateral lung (whether open-heart surgery or thoracoscopic surgery)
- There is no history of chemotherapy, including treatment for other cancer types (including molecular targeted therapies and immune checkpoint inhibitors). However, the history of drug therapy as adjuvant therapy is allowed if it was completed more than 3 years ago. In addition, a history of hormone therapy for other cancer types is allowed.
- If there is a history of radiotherapy including other cancer types, the lung, hilum, mediastinum, and supraclavicular fossa are not included in the irradiation field.
- Chest CT does not show interstitial pneumonia or pulmonary fibrosis.
- No history of complication of autoimmune disease or chronic or recurrent autoimmune disease. However, patients with type 1 diabetes which is well controlled by appropriate treatment, hyperthyroidism/hypothyroidism that requires only antithyroid drug/hormone replacement therapy, autoimmune skin disease that does not require systemic treatment (Pemphigus, psoriasis vulgaris, pemphigus vulgaris, vitiligo), and celiac disease controlled only by dietary control are regarded as eligible if they have been inactive in the past 5 years, even with a history of autoimmune complications or history.
- No surgical treatment with general anesthesia within 14 days (2 weeks) before registration.
- No systemic administration of steroids, other immunosuppressive drugs, or immunoglobulins within 28 days (4 weeks) before registration. However, those that meet the following conditions are allowed.
- Intranasal/inhalation/topical steroid injection or local steroid injection (for example, intra-articular injection) II. Systemic administration of steroid drugs at a dose of 10 mg/day or less in terms of prednisolone III. Steroids as premedication (eg CT premedication)
- Can be taken orally.
- No ischemic changes were observed on the latest 12-lead ECG within 28 days before registration. However, if a 12-lead electrocardiogram shows ischemic changes, echocardiography, exercise electrocardiography, etc. should be performed, and if it is judged that new treatment for ischemic heart disease is not necessary, it is qualified.
- The latest inspection value within 14 days before registration (possible on the same day two weeks before the registration date) satisfies all of the following.
- White blood cell count ≧4,000/mm3 II. Hemoglobin ≥ 11.0 g/dL (no blood transfusion within 14 days before the blood sampling date of the test used for registration) III. Platelet count ≧10×104 /mm3 IV. Total bilirubin ≤ 2.0 mg/dL V. AST ≤ 75 U/L VI. ALT ≤ 75 U/L VII. Serum creatinine ≤ 1.2 mg/dL
- Written informed consent from the patient to participate in the study.
- The attending physician can judge that the enrolled patients understand the treatment and evaluation schedule of this study and can comply with them.
Who cannot join
- Having active double cancer (simultaneous double cancer/multiple cancer and metachronous double cancer/multiple cancer with a disease-free period of 3 years or less, even if the disease-free period is less than 3 years, clinical The 5-year relative survival rate is similar to that of stage I prostate cancer, clinical stage 0 completely responded to radiation therapy, stage I laryngeal cancer, and complete excision of the following pathological stage cancers. History of cancer equivalent to 95% or more is not included in active double cancer/multiple cancer). Gastric cancer "adenocarcinoma (general type)": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I, rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma, glandular) Squamous cell carcinoma, basal cell carcinoma): Stage 0, breast cancer (non-invasive ductal carcinoma, lobular carcinoma): Stage 0, breast cancer (invasive ductal carcinoma, lobular invasive carcinoma, Paget's disease): 0 Stage-IIA, endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, prostate cancer (adenocarcinoma): Stage I-II, cervical cancer (squamous cell carcinoma): Stage 0, thyroid cancer (Papillary cancer, follicular cancer): stage I, stage II, stage III, renal cancer (clear cell carcinoma, chromophobe cell carcinoma): stage I, non-melanoma skin cancer, malignant melanoma without a definite diagnosis, etc. Lesions of intramucosal cancer
- Has an infectious disease that requires systemic treatment (including active pulmonary tuberculosis).
- When registering, a fever of 38.0°C or higher is generated.
- Women who are pregnant, possibly pregnant, within 28 days of delivery, or breastfeeding. A man who wants a partner to become pregnant. Or a reproductive male or female patient who is not willing to use an effective contraceptive by Week 13 (Day 91) after the last dose of durvalumab (see 6.4.7.).
- Participation in the study is considered to be difficult due to the combination of mental illnesses or symptoms that impair daily life.
- Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressive drugs in excess of 10 mg/day in terms of prednisolone.
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- With uncontrolled diabetes.
- With uncontrolled hypertension.
- A gastrointestinal disorder accompanied by uncontrolled diarrhea.
- With unstable angina (angina with onset or exacerbation of attack within the last 3 weeks) or a history of myocardial infarction within 6 months.
- Poor valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congestive heart failure, and arrhythmia.
- Chest CT reveals severe emphysema.
- Either HBs antigen, HCV antibody, or HIV1/2 antibody is positive.
- Continuous use of flucytosine (Ancotil®) is required.
- Participating in another clinical trial (excluding observational studies) during the 6 months prior to enrollment.
- A history of allogeneic organ transplant.
- A history of active primary immunodeficiency.
- Live vaccines (BCG, polio, measles-rubella mixture, measles, rubella, mumps, chickenpox, yellow fever, rotavirus, etc.) have been administered within 30 days before registration.
- Has hypersensitivity or allergy to the test drug or its additives used in this test.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Durvalumab Before and After Operation or Durvalumab as Maintenance Therapy After Chemoradiotherapy Against Superior Sulcus Non-small Cell Lung Cancer
The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
Read the detailed description
To evaluate the safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
- Conditions
- Superior Sulcus Tumor, Non-small Cell Lung Cancer Stage IIB, Non Small Cell Lung Cancer Stage III
- Being tested
- Cisplatin, S1, concurrent radiotherapy, Durvalumab, Surgery
- Keywords
- Superior Sulcus Tumor, Pancoast Tumor, Non-Small Cell Lung Cancer, Durvalumab, Multi-modality therapy, Neoadjuvant therapy
- Medical subject headings
- Pancoast Syndrome, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin 60 mg/m2, IV, day 1
S1Drug
80 - 120 mg/day, PO, day 1-14
concurrent radiotherapyRadiation
66 Gy/33 Fr
DurvalumabDrug
preoperative durvalumab therapy within 28 days after chemoradiotherapy. Two courses are given every two weeks.
SurgeryProcedure or surgery
Surgery will be performed between day 15 and day 42 of the second course of preoperative durvalumab therapy after confirming that all surgical operation criteria are met.
DurvalumabDrug
(For resectable SST) Postoperative durvalumab therapy will be started between day 28 and day 63 with the day of surgery as Day 1. Twenty-two courses are given as a 2-week course.
Drug: Durvalumab 10 mg/kg/body, IV, day 1 (For unreectable SST) Additional durvalumab therapy between day 15 and day 28 of the second course of preoperative durvalumab therapy.
Twenty-two courses are given as 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1
| Study group | Role | What they receive |
|---|---|---|
| CRT + Durvalumab ± Surgery + Durvalumab | Experimental | Concurrent chemoradiotherapy (cisplatin+S-1+radiotherapy 66Gy)+2 courses of durvalumab followed by Surgery and adjuvant durvalumab for resectable SST or chemoradiotherapy (cisplatin+S-1+radiotherapy 66Gy) followed by maintenance durvalumab for unresectable SST. Receives: Drug: Cisplatin; Drug: S1; Radiation: concurrent radiotherapy; Drug: Durvalumab; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival rate (3y-OS)
3-year overall survival rate
Measured: 3 years
Secondary outcomes (15)
3-year progression-free survival rate (3y-PFS)
3-year progression-free survival rate
Measured: 3 years
5-year progression-free survival rate (5y-PFS)
5-year progression-free survival rate
Measured: 5 years
5-year overall survival rate (5y-OS)
5-year overall survival rate
Measured: 5 years
Mode of recurrence
Mode of recurrence in surgical cases
Measured: 5 years
Local recurrence rate
Proportion of local failure in surgical cases
Measured: 5 years
Objective response rate (ORR)
Objective response rate according to RECIST and iRECIST
Measured: 1 year 6 months
Resection rate
Proportion of surgical cases
Measured: 1 year 6 months
Pathological complete resection rate (R0 rate)
Proportion of pathologcal complete resection in surgical cases
Measured: 1 year 6 months
Pathological complete response rate (pCR rate)
Proportion of pathologcal complete response in surgical cases
Measured: 1 year 6 months
Major pathological response rate (MPR rate)
Determination of major pathologic response rate is based on the method by Hellmann et al. on the pathological section. The percentage of residual tumor cells is calculated as viable tumor cells / tumor area × 100 (%). Tumor area includes viable tumor cells and interstitial tissue such as fibrosis, necrosis, and inflammatory cells.
Measured: 1 year 6 months
Operation time
Operation time in surgical cases
Measured: 1 year 6 months
Blood loss
Intraoperative blood loss in surgical cases
Measured: 1 year 6 months
Adverse event rate
Measured: 1 year 6 months
Incidences of serious adverse events
Measured: 1 year 6 months
Incidences of adverse events
Measured: 1 year 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Sulcus TumorStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center Hospital East
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Japan Agency for Medical Research and Development, Japan Clinical Oncology Group
- Responsible party
- Principal investigator, Masahiro Tsuboi, National Cancer Center Hospital East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465968
- Sponsor's protocol ID
- JCOG1807C
- Acronym
- DEEP_OCEAN
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Durvalumab Before and After Operation or Durvalumab as Maintenance Therapy After Chemoradiotherapy Against Superior Sulcus Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04465968
- Acronym / sponsor ID
- DEEP_OCEAN / JCOG1807C
- Conditions
- Superior Sulcus Tumor, Non-small Cell Lung Cancer Stage IIB, Non Small Cell Lung Cancer Stage III
- Keywords
- Superior Sulcus Tumor, Pancoast Tumor, Non-Small Cell Lung Cancer, Durvalumab, Multi-modality therapy, Neoadjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Cancer Center Hospital EastUniversity, hospital or other
- Collaborators
- AstraZeneca, Japan Agency for Medical Research and Development, Japan Clinical Oncology Group
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 10 Jul 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.
The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
Detailed description
To evaluate the safety and efficacy of multimodality treatment of pre- and post-operative durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT + Durvalumab ± Surgery + Durvalumab | Experimental | Drug: Cisplatin, Drug: S1, Radiation: concurrent radiotherapy, Drug: Durvalumab, Procedure: SurgeryConcurrent chemoradiotherapy (cisplatin+S-1+radiotherapy 66Gy)+2 courses of durvalumab followed by Surgery and adjuvant durvalumab for resectable SST or chemoradiotherapy (cisplatin+S-1+radiotherapy 66Gy) followed by maintenance durvalumab for unresectable SST. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from the primary lesion.
- Meet all of the following (UICC-TNM classification 8th edition). I. Regarding the primary lesion, meet one of the following on chest CT. i. Direct invasion of the chest wall at or above the height of the first rib (at least invasion of the parietal pleura) ii. Direct invasion of the subclavian artery or vein II. Regarding regional lymph nodes, meet either of the following by chest CT and FDG-PET/CT. Metastasis is also considered if lymph node metastasis is determined by either chest CT or FDG-PET/CT.
- It is judged that radical resection is possible by lobectomy (including bilobectomy for 2 lobes), which satisfies the following [1] and [2].
- Consult with the radiotherapy doctor and it is judged that all of the following are met.
- The age of the registration date is 20 years or older and 75 years or yonger.
Key exclusion criteria (19 listed)
- Having active double cancer (simultaneous double cancer/multiple cancer and metachronous double cancer/multiple cancer with a disease-free period of 3 years or less, even if the disease-free period is less than 3 years, clinical The 5-year relative survival rate is similar to that of stage I prostate cancer, clinical stage 0 completely responded to radiation therapy, stage I laryngeal cancer, and complete excision of the following pathological stage cancers. History of cancer equivalent to 95% or more is not included in active double cancer/multiple cancer). Gastric cancer "adenocarcinoma (general type)": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I, rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma, glandular) Squamous cell carcinoma, basal cell carcinoma): Stage 0, breast cancer (non-invasive ductal carcinoma, lobular carcinoma): Stage 0, breast cancer (invasive ductal carcinoma, lobular invasive carcinoma, Paget's disease): 0 Stage-IIA, endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I, prostate cancer (adenocarcinoma): Stage I-II, cervical cancer (squamous cell carcinoma): Stage 0, thyroid cancer (Papillary cancer, follicular cancer): stage I, stage II, stage III, renal cancer (clear cell carcinoma, chromophobe cell carcinoma): stage I, non-melanoma skin cancer, malignant melanoma without a definite diagnosis, etc. Lesions of intramucosal cancer
- Has an infectious disease that requires systemic treatment (including active pulmonary tuberculosis).
- When registering, a fever of 38.0°C or higher is generated.
- Women who are pregnant, possibly pregnant, within 28 days of delivery, or breastfeeding. A man who wants a partner to become pregnant. Or a reproductive male or female patient who is not willing to use an effective contraceptive by Week 13 (Day 91) after the last dose of durvalumab (see 6.4.7.).
- Participation in the study is considered to be difficult due to the combination of mental illnesses or symptoms that impair daily life.
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 |
|---|---|---|
| CisplatinCisplatin 60 mg/m2, IV, day 1 | Drug | CRT + Durvalumab ± Surgery + Durvalumab |
| S180 - 120 mg/day, PO, day 1-14 | Drug | CRT + Durvalumab ± Surgery + Durvalumab |
| concurrent radiotherapy66 Gy/33 Fr | Radiation | CRT + Durvalumab ± Surgery + Durvalumab |
| Durvalumabpreoperative durvalumab therapy within 28 days after chemoradiotherapy. Two courses are given every two weeks. | Drug | CRT + Durvalumab ± Surgery + Durvalumab |
| SurgerySurgery will be performed between day 15 and day 42 of the second course of preoperative durvalumab therapy after confirming that all surgical operation criteria are met. | Procedure or surgery | CRT + Durvalumab ± Surgery + Durvalumab |
| Durvalumab(For resectable SST) Postoperative durvalumab therapy will be started between day 28 and day 63 with the day of surgery as Day 1. Twenty-two courses are given as a 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1 (For unreectable SST) Additional durvalumab therapy between day 15 and day 28 of the second course of preoperative durvalumab therapy. Twenty-two courses are given as 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1 | Drug | CRT + Durvalumab ± Surgery + Durvalumab |
Primary outcome
3-year overall survival rate (3y-OS)
Time frame: 3 years
3-year overall survival rate
15 secondary outcomes
3-year progression-free survival rate (3y-PFS)
Time frame: 3 years
5-year progression-free survival rate (5y-PFS)
Time frame: 5 years
5-year overall survival rate (5y-OS)
Time frame: 5 years
Mode of recurrence
Time frame: 5 years
Local recurrence rate
Time frame: 5 years
Objective response rate (ORR)
Time frame: 1 year 6 months
Resection rate
Time frame: 1 year 6 months
Pathological complete resection rate (R0 rate)
Time frame: 1 year 6 months
Pathological complete response rate (pCR rate)
Time frame: 1 year 6 months
Major pathological response rate (MPR rate)
Time frame: 1 year 6 months
Operation time
Time frame: 1 year 6 months
Blood loss
Time frame: 1 year 6 months
Adverse event rate
Time frame: 1 year 6 months
Incidences of serious adverse events
Time frame: 1 year 6 months
Incidences of adverse events
Time frame: 1 year 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Superior Sulcus Tumor
Active, not recruitingPhase 2
DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors
NSCLC, Pancoast Tumor
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin, S1 and concurrent radiotherapy in people with Superior Sulcus Tumor and Non-small Cell Lung Cancer Stage IIB, run by National Cancer Center Hospital East.
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 26 inclusion and 19 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: opening soon, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Masahiro Tsuboi, MD (+81-4-7133-1111 ext. 91373, mtsuboi@east.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year overall survival rate (3y-OS) (time frame: 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 10 Jul 2020.