ClinicalTrials.gg
Sign In
Active, not recruitingNCT02194738Updated Oct 26, 2026

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

An interventional study of Biospecimen Collection and Carboplatin in Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7 and Stage IIA Lung Cancer AJCC v8, sponsored by National Cancer Institute (NCI). Active, not recruiting at 1,660 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Screening

Updated Oct 26, 20263 sites added3 sites removedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
7,458
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Read the detailed description

PRIMARY OBJECTIVES:

I. To centrally test resected non-small cell lung cancer (NSCLC) for genetic mutations to facilitate accrual to randomized adjuvant studies.

II. To obtain clinically annotated tumor tissue and patient-matched non-malignant deoxyribonucleic acid (DNA) from peripheral blood, as well as detailed epidemiologic and clinical follow-up data, to allow clinically annotated advanced genomic analyses in concert with the National Cancer Institute (NCI) Center for Cancer Genomics (CCG).

SECONDARY OBJECTIVES:

I. To characterize the natural history of molecularly characterized NSCLC to allow subsequent development of targeted therapies against genotype-defined subpopulations in the adjuvant and recurrent settings.

II. To cross-validate local genotyping assays for EGFR and ALK and PD-L1 immunohistochemistry (IHC) with a central reference standard, when available.

EXPLORATORY/OTHER OBJECTIVES:

I. To study the genomic evolution of lung cancers by comparing genomic characteristics at resection and at recurrence.

II. To understand reasons behind lack of enrollment to adjuvant targeted therapy studies for potentially eligible patients.

III. To study the clinical significance of circulating tumor DNA within the plasma cell-free DNA (cfDNA) from early stage lung cancer patients.

IV. To perform proteomic analyses on lung cancer specimens obtained at the time of resection (to identify prognostic biomarkers).

OUTLINE:

STEP 1 (SCREENING): Patients undergo collection of blood and tissue samples for EGFR, ALK, and programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1)/cytotoxic t-lymphocyte-associated protein 4 (CTLA-4) testing via direct sequencing, fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing.

STEP 2 (TREATMENT): Patients with a mutation targeted by one or more of the investigational drugs used in this study or those without mutations are assigned to 1 of 4 treatment subprotocols.

A081105: Patients are randomized to 1 of 4 treatment arms.

ARM A (BLINDED ERLOTINIB- CLOSED 06/14/17): Blinded patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B (PLACEBO- CLOSED 06/14/17): Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM C (UNBLINDED ERLOTINIB): Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM D (OBSERVATION): Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.

E4512: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive crizotinib PO twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B: Patients undergo observation.

EA5142: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET)/CT throughout the trial and blood sample collection during screening and follow-up. Patients may undergo an echocardiography (ECHO) as clinically indicated on study.

ARM II: Patients are followed serially with CT and/or PET/CT imaging for up to 1 year and then during follow-up. Patients also undergo blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.

A081801: Patients are randomized to 1 of 3 arms.

ARM A:

INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CONTINUANCE THERAPY: Patients then undergo observation.

ARM B:

INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

CONTINUANCE THERAPY: Patients then receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1. Treatment repeats every 21 days for 17 cycles in the absence of disease progression or unacceptable toxicity.

ARM C:

INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice and pembrolizumab IV over 25-40 minutes on day 1. 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. Treatment repeats every 21 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

*ACCEPTABLE REGIMENS: DOUBLET I: Patients receive cisplatin IV over 1-2 hours and pemetrexed IV over 10 minutes on day 1 of each cycle.

DOUBLET II: Patients receive carboplatin IV over 30 minutes and pemetrexed IV over 10 minutes on day 1 of each cycle.

DOUBLET III: Patients receive cisplatin IV over 1-2 hours on day 1 of each cycle and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 of each cycle.

DOUBLET IV: Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1 of each cycle.

After completion of study, patients that are not enrolled on either A081105, E4512, EA5142, or A081801 are followed up every 6 months for 5 years.

02

Conditions studied

  • Stage IB Lung Non-Small Cell Carcinoma AJCC v7
  • Stage II Lung Non-Small Cell Cancer AJCC v7
  • Stage IIA Lung Cancer AJCC v8
  • Stage IIB Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIA Lung Non-Small Cell Cancer AJCC v7
  • Stage IIIB Lung Cancer AJCC v8
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's enrollment of 7,458 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Browse National Cancer Institute (NCI) studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:

  • For pre-surgical patients

    • Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology; patients with squamous cell carcinoma are eligible
    • Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors \< 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized

  • For post-surgical patients

    • Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if they have not received therapy
    • Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors \< 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized
  • (ECOG) performance status 0-1
  • Age ≥ 18 years
  • No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer
  • No locally advanced or cancer requiring systemic therapy within 5 years prior to registration; no secondary primary lung cancer diagnosed concurrently or within 2 year prior to registration
  • No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and /PD-L1/CTLA-4
  • No patients known to be pregnant or lactating
  • Patients who have had local genotyping are eligible, regardless of the local result
  • No patients with recurrence of lung cancer after prior resection
  • Note: Post-surgical patients should proceed to registration immediately following preregistration
  • PATIENT REGISTRATION ELIGIBILITY CRITERIA:
  • Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
  • Completely resected NSCLC with negative margins (R0); cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus a "nonsquamous" histology
  • Pathologic stage IIIA, IIA or IIB, or large IB (defined as size >= 4 cm); Note: IB tumors \< 4 cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4 cm; the 7th edition of AJCC staging will be utilized
  • Patients with squamous cell carcinoma are eligible only if they have not received adjuvant therapy

  • In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows:

    • Squamous patients:

      • No adjuvant therapy permitted, register patient within 77 days following surgery

    • Non-squamous patients:

      • If no adjuvant therapy, register patient within 75 days following surgery
      • If adjuvant chemotherapy or radiotherapy only, register patient within 225 days following surgery
      • If adjuvant chemotherapy and radiation, register patient within 285 days following surgery
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,458 participants (actual)

Study arms

  • Experimental
    A081105 Arm A (blinded erlotinib hydrochloride)

    Blinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)

    Other: Cytology Specimen Collection Procedure

  • Placebo comparator
    A081105 Arm B (placebo)

    Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)

    Other: Cytology Specimen Collection Procedure · Other: Placebo Administration

  • Experimental
    A081105 Arm C (unblinded erlotinib hydrochloride)

    Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

    Other: Cytology Specimen Collection Procedure · Drug: Erlotinib

  • Active comparator
    A081105 Arm D (observation)

    Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.

    Other: Clinical Observation · Other: Cytology Specimen Collection Procedure

  • Active comparator
    A081801 Arm A (platinum doublet, observation)

    INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CONTINUANCE THERAPY: Patients then undergo observation.

    Drug: Carboplatin · Drug: Cisplatin · Other: Clinical Observation · Drug: Gemcitabine Hydrochloride · Drug: Paclitaxel · Drug: Pemetrexed · Drug: Pemetrexed Disodium

  • Experimental
    A081801 Arm B (platinum doublet, sequential pembrolizumab)

    INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice. 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. Treatment repeats every 21 days for 17 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Carboplatin · Drug: Cisplatin · Drug: Gemcitabine Hydrochloride · Drug: Paclitaxel · Biological: Pembrolizumab · Drug: Pemetrexed · Drug: Pemetrexed Disodium

  • Experimental
    A081801 Arm C (platinum doublet, combination pembrolizumab)

    INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice and pembrolizumab IV over 25-40 minutes on day 1. 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. Treatment repeats every 21 days for 13 cycles in the absence of disease progression or unacceptable toxicity.

    Drug: Carboplatin · Drug: Cisplatin · Drug: Gemcitabine Hydrochloride · Drug: Paclitaxel · Biological: Pembrolizumab · Drug: Pemetrexed · Drug: Pemetrexed Disodium

  • Experimental
    E4512 Arm A (crizotinib)

    Patients receive crizotinib PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

    Drug: Crizotinib · Other: Cytology Specimen Collection Procedure

  • Active comparator
    E4512 Arm B (observation)

    Patients undergo observation.

    Other: Clinical Observation · Other: Cytology Specimen Collection Procedure

  • Experimental
    EA5142 Arm I (nivolumab)

    Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT throughout the trial and blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated.

    Procedure: Biospecimen Collection · Procedure: Computed Tomography · Other: Cytology Specimen Collection Procedure · Procedure: Echocardiography Test · Biological: Nivolumab · Procedure: Positron Emission Tomography

  • Active comparator
    EA5142 Arm II (observation)

    Patients are followed serially with CT and/or PET/CT imaging for up to 1 year and then during follow-up. Patients also undergo blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.

    Procedure: Biospecimen Collection · Other: Clinical Observation · Procedure: Computed Tomography · Other: Cytology Specimen Collection Procedure · Procedure: Echocardiography Test · Procedure: Positron Emission Tomography

Interventions

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • DrugCarboplatin

    Given IV

    Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

  • DrugCisplatin

    Given IV

    Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

  • OtherClinical Observation

    Undergo observation

    Also known as: observation

  • ProcedureComputed Tomography

    Undergo CT or PET/CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • DrugCrizotinib

    Given PO

    Also known as: Alkixen, Crizocent, MET Tyrosine Kinase Inhibitor PF-02341066, PF 02341066, PF-02341066, PF-2341066, PF02341066, Xalkori

  • OtherCytology Specimen Collection Procedure

    Undergo collection of blood and tissue

    Also known as: Cytologic Sampling

  • ProcedureEchocardiography Test

    Undergo ECHO

    Also known as: EC, Echocardiography

  • DrugErlotinib

    Given PO

  • DrugGemcitabine Hydrochloride

    Given IV

    Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011

  • BiologicalNivolumab

    Given IV

    Also known as: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo

  • DrugPaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

  • BiologicalPembrolizumab

    Given IV

    Also known as: BCD-201, GME 751, GME751, Keytruda, Lambrolizumab, MK 3475, MK-3475, MK3475, Pembrolizumab Biosimilar BCD-201, Pembrolizumab Biosimilar GME751, Pembrolizumab Biosimilar QL2107, Pembrolizumab Biosimilar RPH-075, Pembrolizumab Biosimilar SB27, QL2107, RPH 075, RPH-075, RPH075, SB 27, SB-27, SB27, SCH 900475, SCH-900475, SCH900475

  • DrugPemetrexed

    Given IV

    Also known as: MTA, Multitargeted Antifolate, Pemfexy

  • DrugPemetrexed Disodium

    Given IV

    Also known as: Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

  • OtherPlacebo Administration

    Given PO

  • ProcedurePositron Emission Tomography

    Undergo PET/CT

    Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

06

What researchers measure

Primary outcomes

  1. Central and local clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105

    Central and local clinical genotyping to facilitate accrual to the adjuvant Intergroup studies, E4512 and A081105, will be measured by the rate of accrual.

    Time frame: Up to 4 years

  2. Feasibility of research grade formalin-fixed, paraffin-embedded tissue collection for Center for Cancer Genomics (CCG) analysis

    Research grade formalin-fixed, paraffin-embedded tissue collection for Center for CCG analysis, will be measured by adequate specimens collected per month.

    Time frame: Up to 4 years

Secondary outcomes

  1. Disease free survival (DFS) rate for lung cancers which are wild-type for EGFR and ALK

    Using genomics performed at CCG, DFS rate will be calculated for each genotype-defined population constituting greater than 1% of the study cohort.

    Time frame: Time from resection to the earliest of documented disease recurrence confirmed by biopsy, development of a new lung cancer confirmed by biopsy, or death from any cause, assessed at 2 years

  2. Agreement of local genotyping methods (direct sequencing of EGFR, ALK fluorescence in situ hybridization [FISH]) with central Clinical Laboratory Improvement Amendments genotyping

    For each locally used assay, agreement will be defined as the proportion of patients deemed mutant (or wild-type) by local and central assessment divided by the number of evaluable patients, where an evaluable patient is one who has a local assessment result and has submitted tissue for central assessment. An agreement rate of 90% or higher between the local assay and the central assessment will be deemed acceptable.

    Time frame: Up to 5 years

Other outcomes

  1. Spectrum of new mutations identified at recurrence

    Genomic analysis will be performed on tissue collected at time of recurrence and compared to baseline genomics. New mutations in key oncogenes and tumor suppressor genes (phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha and phosphatase and tensin homolog, etc) will be quantified.

    Time frame: Up to 5 years

  2. Proportions of patients who decline to enroll

    Reasons behind why potentially eligible ALK-rearranged/EGFR mutant patients decline to enroll onto the adjuvant trials will be summarized. Concern with randomization, or not needing further therapy versus those who become otherwise ineligible due to recurrent disease or missing the enrollment window will be catalogued.

    Time frame: Up to 5 years

  3. Variability in the levels of baseline cell-free deoxyribonucleic acid (cfDNA) based on the timing of collection of these samples

    The levels of cfDNA (stratified by the timing of collection) will be correlated with clinical outcomes of overall survival and disease-free survival using Kaplan-Meier approach as well as exploratory Cox proportional Hazards models adjusted for baseline smoking, patient, and tumor characteristics as well as treatment information.

    Time frame: Up to 4 years

07

Study locations

1,660 sites

Showing the first 100 of 1,660 sites across 3 countries. Choose a country and city above to see the rest.

08

References and documents

Publications

  • Kehl KL, Zahrieh D, Yang P, Hillman SL, Tan AD, Sands JM, Oxnard GR, Gillaspie EA, Wigle D, Malik S, Stinchcombe TE, Ramalingam SS, Kelly K, Govindan R, Mandrekar SJ, Osarogiagbon RU, Kozono D. Rates of Guideline-Concordant Surgery and Adjuvant Chemotherapy Among Patients With Early-Stage Lung Cancer in the US ALCHEMIST Study (Alliance A151216). JAMA Oncol. 2022 May 1;8(5):717-728. doi: 10.1001/jamaoncol.2022.0039. PubMed 35297944 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2014 to primary completion in Dec 2025, 134 months.

Of 343 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's 134 months is above that.

Counting every sponsor, half of 359 studies reached it within 51 months; a quarter within 26 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2014
First posted
Jul 18, 2014
StartActual
Sep 26, 2014
Primary completionActual
Dec 3, 2025
CompletionEst.
Sep 21, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
3 sites added, 3 sites removed
Show 3 added (3 United States)
  • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
  • Saint Anne Hospital · Burien, United States
  • Trinity Health IHA Medical Group-Alice Gustafson Center · Pontiac, United States
Show 3 removed
  • West Virginia University Charleston Division · Charleston, United States
  • Highline Medical Center-Main Campus · Burien, United States
  • Newland Medical Associates-Pontiac · Pontiac, United States
across 3 updates, Oct 1, 2026 – Oct 26, 2026
Show all 3 updates
  1. Oct 26, 2026
    1 site added, 1 site removed
    Show site
    • Trinity Health IHA Medical Group-Alice Gustafson Center · Pontiac, United States
    Show 1 removed
    • Newland Medical Associates-Pontiac · Pontiac, United States
  2. Oct 22, 2026
    1 site added, 1 site removed
    Show site
    • Saint Anne Hospital · Burien, United States
    Show 1 removed
    • Highline Medical Center-Main Campus · Burien, United States
  3. Oct 1, 2026
    1 site added, 1 site removed
    Show site
    • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
    Show 1 removed
    • West Virginia University Charleston Division · Charleston, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02194738
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 18, 2014
Start date
Sep 26, 2014
Primary completion
Dec 3, 2025
Completion
Sep 21, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

David E Kozono
principal investigator · Alliance for Clinical Trials in Oncology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Nivolumab

Other studies in this condition

Carcinoma, Non-Small-Cell Lung →

Other studies from this sponsor

National Cancer Institute (NCI) →

Start the discussion