NCT04267848ClinicalTrials.gov
Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)
باختصار
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as…
المرحلة 3مطلوب 1,210 مشاركين1,151 موقعاًدولتان
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT04267848فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل أسبوعين
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2020-02-13; recorded start 2020-06-16
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 1548 other studies in this databaseCounted from the lead sponsor named in the record (National Cancer Institute (NCI))
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 6 conditions.
- Lead sponsor type recorded as: US National Institutes of Health.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding0/20
Open-label
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 1151 sites
- Data monitoring committee0/7
No data monitoring committee stated
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 1,210 participants (target), run at 1,151 sites, across 2 countries.
How this score is built
- Enrolment31/40
1,210 participants (target)
- Site count25/25
1,151 sites
- Country count7/15
2 countries
- Planned duration10/10
Planned over about 81 months
- Sponsor scale10/10
National Cancer Institute (NCI) has led 1,534 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
ملخص
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.
الحالات
- Lung Non-Small Cell Carcinoma
- Lung Non-Small Cell Squamous Carcinoma
- Lung Non-Squamous Non-Small Cell Carcinoma
- Stage II Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 3 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | NONE (0) |
| التجنيد | مطلوب 1,210 مشاركين |
الجهة الراعية والمتعاونون
- National Cancer Institute (NCI) الجهة الراعية
الأذرع والتدخلات
- Arm A (platinum doublet, observation)ACTIVE_COMPARATOR
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then undergo observation. Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial. (CLOSED AS OF UPDATE #7)
- Arm B (platinum doublet, sequential pembrolizumab)EXPERIMENTAL
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.
- Arm C (platinum doublet, combination pembrolizumab)EXPERIMENTAL
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo a MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.
التدخلات
- إجراء Biospecimen Collection
Undergo blood sample collection
- دواء Carboplatin
Given IV
- دواء Cisplatin
Given IV
- إجراء Computed Tomography
Undergo CT
- إجراء Echocardiography Test
Undergo ECHO
- دواء Gemcitabine Hydrochloride
Given IV
- إجراء Magnetic Resonance Imaging
Undergo MRI
- أخرى Observation Activity
Undergo observation
- دواء Paclitaxel
Given IV
- منتج بيولوجي Pembrolizumab
Given IV
- دواء Pemetrexed Disodium
Given IV
- أخرى Questionnaire Administration
Ancillary studies
مقاييس النتائج
مقياس النتيجة الأولي
Disease free survival (DFS)
Will compare DFS between the two arms (combination versus sequential pembrolizumab added to standard of care platinum-based adjuvant therapy) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. Will be estimated using the Kaplan-Meier method, where the stratified log-rank test (using the central PD-L1 result for the PD-L1 expression status) will be used to compare the distributions across the treatment arms. DFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors (using the central PD-L1 result for the PD-L1 expression status) used in the randomization will be assessed as well.
الإطار الزمني From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion
مقياس النتيجة الثانوي
Overall survival (OS)
Will be estimated using the Kaplan-Meier method, where the stratified log-rank test (using the central PD-L1 result for the PD-L1 expression status) will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. Univariable and multivariable Cox models stratified by the stratification factors (using the central PD-L1 result for the PD-L1 expression status) used in the randomization will be assessed as well.
الإطار الزمني From randomization to death from any cause, assessed up to completion of 5 years follow-up
مقياس النتيجة الثانوي
Incidence of adverse events
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5. will compare the adverse event rates and drug discontinuation rates due to adverse events. To evaluate the adverse events profiles associated with each treatment arm, the maximum grade for each type of adverse event will be recorded for each patient and frequency tables will be reviewed to determine the overall patterns. The number and severity of grade 3 + adverse events will be tabulated and summarized. Analysis of the overall adverse event rates, as well as specific events of interest will involve chi-square tests or Fisher's exact tests. In addition, we will also compute and compare the total adverse event burden for each arm
الإطار الزمني Up to 10 years
مقياس النتيجة الثانوي
DFS between each of the arms
Will compare the DFS by PD-L1 expression status (tumor proportion score \[TPS\] ≥ 50% versus \[vs\] TPS \< 50% using the central PD-L1 expression status) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. This will be assessed using the treatment arm by PD-L1 expression status (using the central PD-L1 expression status) interaction effect on DFS. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models. Similar analyses will be performed for the correlative endpoints using the cut off of 1% for the PD-L1 expression status (using the central PD-L1 expression status), and tumor mutational burden (high vs low).
الإطار الزمني From randomization to the first of either disease recurrence or death from any cause, assessed up to 5 years after accrual completion
مقياس النتيجة الثانوي
OS between each of the arms
will compare the OS by PD-L1 expression status (TPS ≥ 50% vs TPS \< 50% using the central PD-L1 expression status) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer. This will be assessed using the treatment arm by PD-L1 expression status (using the central PD-L1 expression status) interaction effect on OS. Univariable and multivariable Cox models stratified by the stratification factors used in the randomization will be used as the primary analytical method, where all baseline covariates will be considered in the univariable models and subsequently in the multivariable models based on the criteria for selection for the multivariable models. Similar analyses will be performed for the correlative endpoints using the cut off of 1% for the PD-L1 expression status (using the central PD-L1 expression status), and tumor mutational burden (high vs low).
الإطار الزمني From randomization to death from any cause, assessed up to completion of 5 years of follow-up
مقياس نتيجة آخر
Patient-reported quality of life (QOL)
Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core (C)30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B), and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C). All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. Will be summarized descriptively for patients randomized to receive adjuvant chemotherapy + observation (Arm A). Correlation analysis and logistic regression analysis will be used to examine whether baseline patient characteristics and prognostic factors predict missingness.
الإطار الزمني Up to 1 year after randomization
مقياس نتيجة آخر
Patient-reported QOL
Assessed by the EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B) and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C).All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. Will be summarized descriptively for patients randomized to receive adjuvant chemotherapy + observation (Arm A). Correlation analysis and logistic regression analysis will be used to examine whether baseline patient characteristics and prognostic factors predict missingness.
الإطار الزمني Up to completion of chemotherapy
مقياس نتيجة آخر
Patient-reported dyspnea and coughing
Assessed by the EORTC QLQ-Lung Cancer 13. All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. All questionnaires will be scored according to published scoring algorithms, including recommendations for addressing missing items within a scale. Will be summarized descriptively for patients randomized to receive adjuvant chemotherapy + observation (Arm A). Correlation analysis and logistic regression analysis will be used to examine whether baseline patient characteristics and prognostic factors predict missingness.
الإطار الزمني Up to 2 years after randomization
التواريخ
| تاريخ البدء | 16 يونيو 2020 (فعلي) |
|---|---|
| الإتمام الأولي | 31 يناير 2027 (تقديري) |
| الإتمام | 31 يناير 2027 (تقديري) |
| أول نشر | 13 فبراير 2020 (فعلي) |
| آخر تحديث | 8 سبتمبر 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | يوليو 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
627 موقعاً قيد التجنيد
Guam
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| FHP Health Center-Guam | Tamuning | مُعلَّق |
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | مُعلَّق |
| Hendrick Medical Center | Abilene | Texas | قيد التجنيد |
| Hickman Cancer Center | Adrian | Michigan | مُعلَّق |
| Riverwood Healthcare Center | Aitkin | Minnesota | مُعلَّق |
| Cleveland Clinic Akron General | Akron | Ohio | قيد التجنيد |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | قيد التجنيد |
| Lovelace Medical Center-Saint Joseph Square | Albuquerque | New Mexico | نشط، دون تجنيد |
| Presbyterian Kaseman Hospital | Albuquerque | New Mexico | نشط، دون تجنيد |
| University Cancer Specialists - Alcoa | Alcoa | Tennessee | مُعلَّق |
| Christus Saint Frances Cabrini Hospital | Alexandria | Louisiana | قيد التجنيد |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | قيد التجنيد |
| Aultman Alliance Community Hospital | Alliance | Ohio | مُعلَّق |
| MyMichigan Medical Center Gratiot | Alma | Michigan | مُعلَّق |
| MyMichigan Medical Center Alpena | Alpena | Michigan | مُعلَّق |
| OSF Saint Anthony's Health Center | Alton | Illinois | مُعلَّق |
| UPMC Altoona | Altoona | Pennsylvania | قيد التجنيد |
| The Don and Sybil Harrington Cancer Center | Amarillo | Texas | نشط، دون تجنيد |
| Mary Greeley Medical Center | Ames | Iowa | قيد التجنيد |
| McFarland Clinic - Ames | Ames | Iowa | قيد التجنيد |
| Community Hospital of Anaconda | Anaconda | Montana | قيد التجنيد |
| Kaiser Permanente-Anaheim | Anaheim | California | قيد التجنيد |
| Providence Alaska Medical Center | Anchorage | Alaska | مُعلَّق |
| Alaska Women's Cancer Care | Anchorage | Alaska | مُعلَّق |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | مُعلَّق |
| Katmai Oncology Group | Anchorage | Alaska | قيد التجنيد |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | مُعلَّق |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | مُعلَّق |
| Anchorage Oncology Centre | Anchorage | Alaska | مُعلَّق |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | مُعلَّق |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | قيد التجنيد |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | قيد التجنيد |
| Luminis Health Anne Arundel Medical Center | Annapolis | Maryland | قيد التجنيد |
| Aspirus Cancer Care-Antigo-Volm Cancer Center | Antigo | Wisconsin | قيد التجنيد |
| Kaiser Permanente-Deer Valley Medical Center | Antioch | California | قيد التجنيد |
| Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton | Appleton | Wisconsin | قيد التجنيد |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | قيد التجنيد |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | مُعلَّق |
| PCR Oncology | Arroyo Grande | California | مُعلَّق |
| Cone Health Cancer Center at Asheboro | Asheboro | North Carolina | مُعلَّق |
| Randolph Hospital | Asheboro | North Carolina | مُعلَّق |
| Cone Health MedCenter Asheboro | Asheboro | North Carolina | قيد التجنيد |
| Duluth Clinic Ashland | Ashland | Wisconsin | قيد التجنيد |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | مُعلَّق |
| Northside Hospital | Atlanta | Georgia | قيد التجنيد |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | مُعلَّق |
| Sutter Auburn Faith Hospital | Auburn | California | قيد التجنيد |
| MultiCare Auburn Medical Center | Auburn | Washington | مُعلَّق |
| Hematology Oncology Associates of Central New York-Auburn | Auburn | New York | مُعلَّق |
| Harold Alfond Center for Cancer Care | Augusta | Maine | قيد التجنيد |
يُدرَج 1,101 موقع إضافي في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
- 2 سبتمبر 2026
أُضيف موقع
1 site added (1151 total)
11501151
- 6 أغسطس 2026
أُزيل موقع
1 site removed (1150 total)
11511150